CVM APPROVES FLUOROQUINOLONE PRODUCT FOR USE IN CATTLE
The Food and Drug Administration’s Center for Veterinary Medicine has approved a new animal drug application for the use of enrofloxacin, which is a fluoroquinolone, in cattle for the treatment of bovine respiratory disease associated with Pasteurella haemolytica, Pasteurella multocida, and Haemophilus sommus. The application, which was approved July 24, 1998, was submitted by Bayer Corporation.
The product, which has the trade name of Baytril 100 Injectable Solution, is restricted to use by or on the order of a licensed veterinarian. It is administered by injection and is intended to be used for the treatment of individual animals. The product is not for use in cattle intended for dairy production or in veal calves. Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. Extralabel use of fluoroquinolones in food animals has been prohibited by the FDA.
In an unprecedented initiative, Bayer has voluntarily committed to FDA to immediately take corrective action, up to and including stopping the sale of Baytril 100, should the FDA determine that continued use of the product in cattle presents a risk to public health and provides the company with the scientific evidence on which it based that conclusion. Bayer will be conducting an intensive monitoring program to assess if use of the product contributes to development of bacterial resistance to fluoroquinolones in cattle. Data collected from this program will be submitted regularly to the FDA for evaluation.
In addition to data collected by the firm, data on antimicrobial resistance is collected through the National Antimicrobial Resistance Monitoring System (NARMS) created in the U.S. in January 1996. This program is a collaboration among FDA, CDC, and USDA and monitors shifts in antimicrobial susceptibilities to 17 antimicrobials in zoonotic enteric organisms from both animal and human sources. The food animal specimens are gathered from healthy farm animals and from carcasses of food animals at slaughter. The NARMS was started (and has recently been expanded with resources from the Food Safety Initiative) because of the human health concerns related to the use of antimicrobials in food animals. By detecting resistance early, this system should help ensure the continued safety and efficacy of veterinary antimicrobials.
Post-approval monitoring for the development of bacterial resistance to fluoroquinolones is also being conducted by drug sponsors for other fluoroquinolones approved for use in food animals.
NATIONAL ANTIMICROBIAL RESISTANCE MONITORING SYSTEM (NARMS) UPDATE
by Marissa A. Miller, D.V.M., M.P.H.
The National Antimicrobial Resistance Monitoring System (NARMS) was established in January, 1996 as a collaborative effort among the FDA, U.S. Department of Agriculture (USDA), and the Centers for Disease Control and Prevention (CDC). The system was initiated in response to public health issues associated with the approval of fluoroquinolone products for use in poultry. The NARMS program monitors changes in susceptibilities to 17 antimicrobial drugs of zoonotic enteric pathogens from human and animal clinical specimens, from healthy farm animals, and from carcasses of food-producing animals at slaughter. The objectives of the system include: to provide descriptive data on the extent and temporal trends of antimicrobial susceptibility in Salmonella and other enteric organisms, to facilitate the identification of resistance in humans and animals as it arises, and to provide timely information to veterinarians and physicians. The ultimate goal of these activities is to prolong the lifespan of approved drugs by promoting prudent and judicious use of antimicrobics and taking appropriate public health action. Another important outcome of these activities is the identification of research questions and areas for more detailed investigation. The system is set up as two nearly identical parts: a veterinary arm and a human arm. Veterinary testing is conducted at the Agricultural Research Service’s (ARS) Russell Research Center in Athens, Georgia. Human-origin isolates are sent in by 16 State Departments of Health for testing conducted at the National Center for Infectious Disease, CDC, in Atlanta, Georgia.
Important augmentations of the NARMS program were made possible by funding from the President’s Food Safety Initiative during fiscal year 1998. These augmentations include expanding the scope of the monitoring system and conducting follow-on research and investigations. The most important expansion of the monitoring system has been to include Campylobacter and E. coli isolate testing and reporting on the veterinary side. Human Campylobacter isolates had been included in the monitoring system beginning in 1997. In addition, new sites and sources of isolates have been added. In fiscal year 1998 the veterinary system is incorporating large numbers of Hazard Analysis Critical Control Point (HACCP) isolates into its sample to reflect the risk from resistant pathogens in the food supply. In an attempt to mirror the reporting of clinical isolates through the human arm, the veterinary arm has incorporated isolate collection from 3 sentinel sites. The three sentinel sites added during 1998 were veterinary diagnostic laboratories in New York, Washington, and California. Additional sentinel sites are to be added in fiscal year 1999.
With the additional funding provided by the Food Safety Initiative Surveillance budget epidemiologic research has been initiated. This research is to characterize and reduce the incidence of foodborne disease associated with emerging and drug-resistant pathogens and includes a field study, several farm-based efforts, and molecular genetic research. FDA in collaboration with ARS and the Vermont Department of Health are currently in the field studying risk factors associated with an outbreak of Salmonella typhimurium DT104 on a Vermont dairy farm. Information from this field study will be used to educate farmers to prevent future outbreaks and spread of this multi-resistant organism among animals and to man. Also in collaboration with ARS and with backing from the poultry industry, on-farm poultry studies have been initiated in 5 states to elaborate management, production, and drug use practices that influence the development of resistant zoonotic pathogens. Collaborative molecular genetic studies have been funded with the National Center for Toxicological Research (NCTR)-a sister FDA Center, to identify regions of fluoroquinolone resistance in zoonotic enteric organisms. This information will be used to develop genetic molecular detection capabilities. Later these techniques will be applied to zoonotic enterics and environmental bacteria to provide improved monitoring for resistance emergence and transfer. This work will significantly improve CVM’s ability to monitor for the safety of competitive exclusion products and new antimicrobial approvals.
Plans for the future include further augmentation of the existing system and new activities. Exciting new activities that will be pursued in fiscal year 1999 pending budget increases include the development of an international veterinary resistance database in order to facilitate international response to resistance emergence and spread throughout the world. Also planned are veterinary and producer drug prescribing surveys to assess the impact of antimicrobial use patterns on resistance emergence and prevalence in collaboration. This work is planned with the Center for Epidemiology and Animal Health, USDA through surveys conducted as part of the National Animal Health Monitoring System.
TOLERANCES ESTABLISHED FOR TETRACYCLINES IN MILK
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) 113-232 filed by Pfizer Animal Health. The supplemental NADA provides for use of Liquamycin LA-200 (oxytetracycline) injection in lactating dairy cattle. Previously, Liquamycin LA-200 was approved for treatment of beef cattle, non-lactating dairy cattle, calves including pre-ruminating (veal) calves, and swine. The supplemental application for use in lactating dairy cattle and a new tolerance for tetracyclines residues in milk were approved by FDA on July 21, 1998.
With this supplementary approval, Liquamycin LA-200 now is labeled for administration to beef cattle, dairy cattle (including lactating dairy cattle), and calves, including pre-ruminating (veal) calves, for the treatment of pneumonia and shipping fever complex associated with Pasteurella spp. and Haemophilus spp., bovine keratoconjunctivitis (pink eye) caused by Moraxella bovis; foot-rot and diphtheria caused by Fusobacterium necrophorum; bacterial enteritis (scours) caused by Escherichia coli; wooden tongue caused by Actinobacillus ligniersii; leptospirosis caused by Leptospira pomona; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline.
Milk taken from animals during treatment with Liquamycin LA-200 and for 96 hours after the last treatment must not be used for food.
The tolerance for tetracyclines including oxytetracycline, chlortetracycline, and tetracycline are amended to provide for an acceptable daily intake (ADI) and for a tolerance for residue in milk. The Center for Veterinary Medicine (CVM) conducted a reevaluation of the toxicology and metabolism data that were used to support the original tolerance for oxytetracycline in edible tissues. The ADI for total residues of tetracyclines including chlortetracycline, oxytetracycline, and tetracycline, is 25 micrograms per kilogram of body weight per day. Sixty percent (60%) of the ADI is reserved for milk and 40% for edible tissues. Based on the ADI, a tolerance of 300 ppb is established for the sum of residues of the tetracyclines including chlortetracycline, oxytetracycline, and tetracycline in milk. With the establishment of a tolerance of 300 ppb for the sum of residues of tetracyclines, a tolerance of 300 ppb for each of the three tetracyclines is also established.
The previously accepted safe levels for oxytetracycline, chlortetracycline, and tetracycline in milk were 30, 30, and 80 ppb respectively for a sum of residues of 140 ppb. The FDA, States, and the dairy industry have regulated milk at these levels since 1991. With the change in tolerance to 300 ppb in milk, there are no longer any FDA accepted rapid screening tests for tetracyclines in raw co-mingled bovine milk. The FDA is currently working with Charm Sciences to modify their Charm II Tetracyclines Drug Test (Competitive) to detect residues at the new tolerance level. FDA encourages other sponsors of tetracyclines kits to submit performance data on the detection of residues of tetracyclines in milk to CVM for evaluation.
Further information about milk screening tests is available from Dr. Norris E. Alderson, FDA/Center for Veterinary Medicine (HFV-500), Office of Research, 8401 Muirkirk Road, Laurel, MD 20708, 301-827-8010. Further information about the tolerances for tetracyclines in milk is available from Dr. Margaret Miller, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-5282.
CVM EPIDEMIOLOGIST RETURNS TO ENGLAND
by Kathy Hollinger, D.V.M., M.P.H.
In 1994-1995 a case control study was performed by the Ministry of Agriculture Fisheries and Food (MAFF) Central Veterinary Laboratory (CVL) to assess risk factors in cattle herds for isolation of the multi-drug resistant pathogen Salmonella typhimurium DT104(StmDT104).
The Recurrent Clinical Disease Study was proposed in 1996 by the Epidemiology Department at CVL to assess the extent of recurrent episodes of S. typhimurium DT104 in affected cattle herds in England and Wales. Information from the 1994-1995 case control study indicated the potential persistence of the organism on cattle farms, for up to 18 months after the first episode on more than 75 percent of 25 farms studied. This led epidemiologists to believe that recurrence of disease and subsequent environmental amplification of the organism from clinically affected animals would lead to the establishment of this organism as an endemic pathogen in cattle herds. The purpose of the study was to assist in the development of a "Code of Practice for the Prevention and Control of Salmonella in Cattle Herds," to be disseminated for use by farmers. In 1997 CVM sent Dr. Kathy Hollinger to CVL to work with Dr. John Wilesmith and Dr. Sarah Evans to develop a protocol for the StmDT104 Recurrent Clinical Disease Case Control Study. Dr. Hollinger designed a study, developed the protocol and tested the survey instrument for the study. Two different test mailings were distributed. The second test mailing included a handwritten note encouraging the participation of the farmers, in an effort to improve the response rate which subsequently increased by almost 40 percent. Dr. Hollinger developed a second survey to describe the education, experience and animal health information to which farmers with herds affected by StmDT104 are most commonly exposed. This was important as CVL wished to return the information to farmers in a format and a resource that would be widely disseminated to the target audience. Other areas of research conducted during her stay in England included researching the origins of the epidemic multi-drug resistant strain, assessing the epidemiology of the epidemic strain from the statutory reporting under the zoonoses order and compiled the StmDT104 susceptibility monitoring surveillance data from 1980 to the present for food animal species and researched additional losses in naladixic acid and trimethoprim susceptibility.
The two questionnaires developed for the study were mailed to farmers in October and November of 1997 from CVL. Follow-up reminders were sent out at one-week intervals from mailing the first questionnaire. A thank-you letter and an information sheet describing risk factors for salmonellosis in cattle were mailed to farmers upon receipt of completed questionnaires. Data was entered at CVL by the Epidemiology Department and checked through double entry procedures. Response rate to the Recurrent Clinical Disease (RCD) questionnaire was approximately 70 percent, very close to the targeted response rate. This was due to a combination of factors. First, the inclusion of a handwritten note, second, notification of the Veterinary Investigation Centers, the branch of MAFF that performs the diagnostic laboratory functions for the farmers and their veterinarians, third, reminder mailings that included the questionnaire and, finally, follow-up telephone reminders to those farmers who had not returned the questionnaire within a month of the first mailing.
In late June 1998 Dr. Hollinger returned to CVL to begin data manipulation and analysis of the two study questionnaires. Activities which Dr. Hollinger carried out during the three-week stay at CVL included review of the data from the Respondent Profile Survey, performing the descriptive and univariate statistical analysis assessing the farmer’s sources of food animal health information and geographic, age and educationally related trends. The results of this analysis were drafted into an article to be submitted for publication in the near future. The data from the RCD survey were manipulated and prepared for analysis. Descriptive analysis was begun looking at risk factors for disease and the evaluating time to recurrent disease comparing vaccinated and non-vaccinated herds. A dataset for multi-variable analysis was prepared. Another data set was prepared to compare data from the 1994-1995 Case Control study and the 1997 RCD study.
In other work, continued research into the origins of the StmDT104 epidemic using Sentest database and other information from imported bird licenses was obtained. Dr. Hollinger reviewed the antimicrobial susceptibility data and emerging trends in StmDT104, tabulated the data, and drafted an article for publication. The data analysis is ongoing and expected to be completed in October. These findings will be prepared for publication.
SUCCESSFUL BSE TELECONFERENCE HELD FOR FEED INDUSTRY
by Jon F. Scheid
The June 24 joint CVM-industry interactive satellite teleconference on the new mammalian feed rules brought in questions ranging from what should the label warning look like, to what records must be kept. While the rule is straight forward, the show proved that, as far as the implementation goes, the "devil is in the details."
What makes implementation of the rule on bovine spongiform encephalopathy (BSE) tough is the complexity of the U.S. feed industry. While feed manufacturers are willing to follow the rules, in many cases they are not sure how.
The solution was a satellite teleconference, produced by CVM, in cooperation with State feed control officials and feed industry trade associations. It was designed specifically to explain the BSE rules to members of the feed industry.
The show was broadcast live. It featured a panel that included CVM and State officials who have a hand in enforcing the rules. Because the show was live, anyone watching the show not only heard from the CVM and State experts about the rule, but also had a chance to call during the show via a toll-free number and ask the panelists questions about how the rule was to be implemented.
The panel also included industry representatives, who made sure that the points made during the show were expressed in terms that were clear to feed mill operators and pointed out practical aspects of complying with the rule.
The broadcast was via satellite, which made it available to virtually anyone in a rural feed mill, or in a corporate office in a major city. The coordinates used to "downlink" the broadcast were publicized for a month before the conference. The nearly two-and-a-half-hour show was free to anyone with access to a "steerable" satellite dish.
The show was a success, with more than 225 downlink sites confirmed in more than 34 States. In addition, since the show aired, there have been dozens of requests for copies of the video. The feed industry trade groups are distributing the tapes, for a charge of $15 each, which covers the cost of reproducing the tape and shipping it.
The CVM panelists were Richard Geyer, Deputy Director of the Office of Surveillance and Compliance, and Gloria Dunnavan, Director of the Division of Compliance. CVM officials were joined on the panel by Herschel Pendell, President of the Association of American Feed Control Officials (AAFCO). He is a State feed control official from Oregon.
The supporting cast from CVM included Dr. Dan McChesney, leader of the Feed Safety Team, and Dr. John Honstead, a Veterinary Medical Officer on the Team.
Representing FDA were Richard Barnes, Office of Regulatory Affairs; Ricky Rodriguez of the Dallas District Office, and coordinator of BSE enforcement for the entire U.S.; and Mike Rogers, Director of FDA’s Kansas City Office.
Also on the show were Richard Sellers of the American Feed Industry Association (AFIA) and Randy Gordon of the National Grain and Feed Association (NGFA). Those two feed groups represent virtually all feed manufacturing companies in the U.S.
The show also featured a taped presentation by CVM Director Dr. Stephen Sundlof, who gave an overview of the rule, explained the reason it was written the way it is, and why the rule is needed.
The broadcast also included a tape made by Dr. Will Hueston, Professor and Chair of the Department of Veterinary Medicine, University of Maryland, and Associate Dean for the Maryland Campus of the Virginia-Maryland Regional College of Veterinary Medicine. Dr. Hueston is also a world-renowned expert in the causes and spread of BSE. He explained how BSE can be transmitted to cattle via feed.
Also, because it is so important for CVM to capture the attention and interest of the commercial feed industry, the broadcast included a tape of introductory comments by David Bossman, president of AFIA, and Kendell Keith, president of NGFA, who explained that the groups they represent support the rule and CVM’s efforts to enforce it. If BSE were to appear in the U.S., the consequences would be devastating for consumers, the cattle industry, and feed producers, they said. They both cited the example of the U.K. Officials there, even after they knew about the disease, did not enforce BSE prevention rules in time to stop the spread of the disease. At the peak in the U.K., 1,000 new cases of BSE in cattle were diagnosed weekly. The U.K.’s beef industry has not fully recovered yet, they said.
Its provisions seem simple. Protein derived from mammalian sources is prohibited in feed for ruminants. Further, all feed or ingredients that contain or may contain mammalian proteins must be labeled with the cautionary statement, "Do not feed to cattle or other ruminants," Dr. Sundlof explained. The rule went into effect in August 1997, although then-existing stocks of product and labels could be used until October 1997.
One of the important exceptions to the rule is that pure porcine (hog) or equine (horse) material, although from mammalian sources, can be used in ruminant feed.
Another complicating factor has to do with the definition of protein. For instance, bone and hide are prohibited from cattle, but tallow is not, because it is not protein.
Feed that contains or might contain mammalian protein is considered prohibited material unless the protein qualifies for one of the exceptions. If prohibited material gets mixed with non-prohibited material, all of the mix must be considered prohibited. Thus, one key question asked and answered during the broadcast was how a feed mill operator can be sure a feed mixer is properly cleaned after a prohibited material has been passed through it. No specific amount or even manner for the cleanout was given. Instead, the answer is that a feed mill operator must determine how to clean his mixer out, and be able to show a State or Federal inspector that the cleanout process is sufficient.
Here is a sampling of some of the questions and answers from the show.
Q: The BSE rule was put in place by CVM. Where does AAFCO fit in?
A: In many areas, the States have the inspectors who will actually be doing the feed mill visits. The State officials have better knowledge of the feed manufacturers in their States, and therefore, can be effective in contacting them all and explaining and enforcing the rule.
Q: The feed industry uses a catch-all term on labels of feed products that identify a type of feed ingredient, without limiting the feed to just one specific ingredient. In that way, a feed manufacturer can switch ingredients and not have to change the feed label. One such term is "animal protein product." Can such terms still be used?
A: Yes, but the use of such terms cause some difficulty for the inspector, who must be sure that the feed is either free of prohibited material, or has the cautionary statement on it. The inspector can’t tell from the term whether the feed contains prohibited material. Therefore, he may have to do a trace back to the source of the animal protein to verify that the feed mill is in compliance.
Q: Where should the cautionary statement be placed on the feed?
A: It must be clearly visible on each feed label for bagged feed. In addition, it should be on the invoice or other document that accompanies any bulk feed shipment.
Q: What should the cautionary statement look like on the label?
A: The statement must be conspicuous. Ms. Dunnavan said during the broadcast, "Remember, the whole point is that the user sees the cautionary statement before using the feed." The label can be in larger type and printed in a different color than the rest of the print on the label. Mr. Pendell said the AAFCO requirements say the cautionary statement should follow the list of ingredients on the label.
Q: If a feed manufacturer uses prohibited material to produce a feed that is meant for swine, which are not ruminants, is the manufacturer subject to the requirements to have a cautionary statement on the feed?
A: Yes. The reason for the cautionary statements is to prevent the feed from being used for ruminants. Without the cautionary statement, a cattle producer might use the feed by mistake.
Q: A key part of the rule is record keeping. Because there is no test for prohibited material, feed manufacturers must keep complete records for the inspector. What records are required?
A: The records must contain information on:
- Date of receipt or purchase.
- Date of sale or delivery.
- Name and address of seller.
- Name and address of consignee.
- Identification of product.
- Quantity of product.
The records must be kept for at least one year.
Q: If a mill does not deal with prohibited material, does it have to maintain records?
A: Not according to the rule. However, a feed manufacturer may have to prove to the satisfaction of an inspector that the mill does not deal with prohibited material. Records would help prove that.
A record of all the questions asked during the broadcast, with answers, will soon be posted on CVM’s Home Page. Also, copies of the tape made from the broadcast are available through the participating trade associations, to members and non-members alike.
To order a tape, contact AFIA at (703) 524-0810, 1500 Wilson Blvd.,
by Estella Z. Jones, D.V.M.
Bouvier des Flandres is French for "cowdog of Flandres". He originated in Flandres, a former province of France and was used as a guard, cartpuller, cattle protector and drover. During World War I, the Bouvier pulled supply carts, delivered messages and detected the living-wounded from the dead on the battlefield. World War II was a difficult time for the Bouvier, especially in France, where long-term breeding programs were lost to a large extent. The World War II Nazi atrocity is illustrated by the fact that registration levels in Belgium during the 1930’s were estimated at 1,000 dogs per year, and were not approached again until the 1960’s. The modern Bouvier evolved out of Belgian reconstruction after the war because French breeding was predominantly an offshoot of the Bouvier des Roulers lines. Mysteriously, the American Kennel Club recognized the Bouvier in the late 1920s, although the first two Bouviers in AKC records were Belgian imports that did not appear until 1931. From 1943 through 1948, only eighteen Bouviers were registered in the United States and the breed was considered almost unknown. The first American standard for the breed was not approved until 1959 and revised in 1975.
Modern times find him as a Seeing Eye Dog, Guard or Police Dog, as well as a family friend, guardian and protector. His intelligence and initiative enable him to also perform as a tracking dog. He loves water and can easily be taught to retrieve. The Bouvier is a rough-coated dog of notably rugged appearance. He is a compact-bodied, powerfully built dog of understated carriage and alert intelligent expression. The Bouvier is loyal, gentle, and carries himself with power and self-confidence. The breed is extremely hardy and males can measure between 24½ to 27½ inches, weighing about 75 to 115 pounds. Although Bouviers can make very good outside dogs, you will miss the strong bond of affection that develops between the Bouvier and its owner when they live together. Since their guard and protective instinct are strong, they will not roam far away from home. They are very calm and will not pace inside the home. Their calm and rational personality, coupled with the fact that shedding is minimal, makes him an excellent in-the-home companion. Although he needs exercise and is willing to work or play to the extent of your energy, he is generally quiet and non-destructive in the house, easily fitting into the domestic routine. One very desirable attribute of the Bouvier is minimal shedding, because the loose hair is held in the rough coat. The Bouvier needs the rough outer coat to provide protection from the elements and the undercoat to provide insulation.
The Bouvier is not -- and should not be -- a dog for every family. There is certainly nothing wrong with doing your research and concluding that you would rather own a Rottweiler, a Labrador Retriever, a Standard Poodle, or a cat. As with other strongly protective breeds, such as the Rottweiler and German Shepherd, the Bouvier should go to a home where he will be taken seriously. Bouviers require from their owners extra commitment, a willingness to work with and train the dog, and especially the assertiveness and confidence necessary to gain and maintain the animal’s respect. Strangers are cautious of their appearance and their bark, but owners can enjoy their faithful behavior and trustworthiness. Although the Bouvier must not be obnoxiously aggressive, a stranger approaching home or automobile will be watched and announced, and any act of overt aggression will be confronted. This keen balance between aggressive protectiveness and respect for other creatures in the routine social context is a key characteristic of the breed. The Bouvier is known for his ability to discriminate — to use his instinctive ability to sense the intent of a potential adversary and then respond accordingly. Most Bouviers are known for having excellent capacity to react appropriately to the situation. Bouviers are accepting of family members and guests, but are also known as dogs that will give a potential troublemaker something to think about. Beyond the protection element, most people obtain a dog to provide companionship, because they expect living with a dog to be a fun, enjoyable experience. The properly bred and raised Bouvier can be a fearless protector, a competitive sport dog, a guardian of livestock, and a most faithful companion.
Much of the character of the adult Bouvier is the consequence of his environment and upbringing. Assertive, strong dogs - like fast and powerful automobiles - are among life’s greatest pleasures but are potentially dangerous when treated as casual diversions. There is simply no more loyal and loving a companion than these unique beasts. Changes in technology have created new work for the modern Bouvier. It is a simple but significant fact that the emphasis for the Bouvier breed must be work, even with a practical modern application (i.e., protection, tracking and searching). Breeding communities must come to the realization that such protective-heritage working breeds must be maintained through selection based on the working test as well as on conformation.
HORSE OWNERSHIP -- A PRIVILEGE AND A RESPONSIBILITY
by Karen A. Kandra
The following article provides information on horses and includes suggestions for their care. Veterinarians may wish to duplicate this article and provide copies to their interested clients. As always, material which appears in the FDA Veterinarian is free of copyright and may be reproduced without permission.
The total equine population in the U. S. numbers approximately six million, but the number of horse owners is increasing rapidly. Prospective owners must realize the extensive commitment in time and money that being a responsible owner entails, since the horse is totally dependent on its caretaker for its welfare. Whether you are lucky enough to stable the horse where you live or employ the services of a local boarding facility, there are many aspects of horse management which should be considered.
Nutrition
Feeding horses is a science wherein the old adage "little and often" must be followed. The horse's stomach is extremely small in relation to its overall size, so it cannot efficiently utilize a large amount of feed at one time. The bulk fiber portion (e.g., forage, pasture, hay) is the most important part of a horse’s diet. Quality grass pasture is the ideal feed for horses and often all that is required for the adult horse. In the winter, or under circumstances when pasture is not available, horses should have good quality hay that is free of dust and mold and does not contain thorny weeds or nonpalatable material. In general, horses should be fed dry hay at a rate of 1.5 to 3.0 percent of their body weight. This quantity should be adjusted depending on the horse’s desired and existing condition, the quality of hay fed, and the expected activity level. Large round bales are an excellent source of hay if made properly and stored inside without exposure to the weather. They also provide activity to keep bored horses from chewing on the fences for lack of anything else to munch on. The quality of hay depends on harvesting management and species of grass or legume. The center and outside of several bales should be evaluated. Generally, the outside of the bale should be dry and light green to yellow in color. The center of the bale should be light green in color and never black or wet. Your local or state extension agent can help you evaluate hay quality.
Ideally, a horse should be fed two or even three times a day. Grain should be considered a supplement to the fiber part of the diet. Grains should be used when additional energy is necessary, or to balance the fiber portion of the diet. There are many commercial feed mixtures available, and you should choose the proper one depending on the intended use and amount of activity your horse will have. Most feeds come in either "textured" or "pelletted" varieties, and each type serves a purpose. Likewise, there are feeds for different life stages, i.e., growing, mature, or senior. Most horses do not require additional vitamin supplements, if fed the appropriate commercial feed. The most important thing is DO NOT OVERFEED. Obesity in horses can negatively impact the respiratory, digestive, and skeletal systems, causing serious conditions such as colic, laminitis (founder), gastric ulcers, and lameness problems.
It goes without saying that horses should have a constant supply of fresh water. Horses on hay drink far more water than horses on pasture. It is also recommended that horses have access to a trace mineral salt block at all times.
The horse's physical condition is totally dependent on the person who feeds him. If his ribs are showing, it is likely he's not getting enough to eat (assuming he does not have parasites). Conversely, if he's obese, he's getting too much. Horses should be fed individually to be sure they get their prescribed amount. If fed in a group, there may be one who wolfs down his own feed and then runs to the other buckets before the more timid horses are finished. Progressive loss in condition despite a good appetite indicates a need for consultation with your veterinarian.
Veterinary Care
When choosing a veterinarian, select one who has an equine practice or at least sees horses 50 percent of the time. Usually you can check with your local veterinary association or other local horse owners for a referral. It is important to develop a good relationship with your veterinarian since there is bound to be a time when you will need to call the doctor out for an emergency.
Consult with your veterinarian to set up a regular health maintenance program to insure against serious diseases. These may vary depending on where you reside, and the expected travel plans for your horse.
Parasites are a leading cause of death, but can be prevented by periodic de-worming and frequent removal and management of manure. Your veterinarian can recommend a specific program based on the number of horses and their environment. For example, two horses on 75 acres of pasture would not have the same exposure level as 50 horses on 75 acres. It is important to reduce the worm burden on the environment, and not just to reduce parasites in a single horse. Pastures should be well drained and properly maintained, i.e., regular mowing and harrowing. Signs of parasites include loss of condition, tail rubbing, dull coat, diarrhea, or constipation. There are several products approved which are effective against different types of parasites.
At least annually, your veterinarian should examine the condition of the horse's mouth and "float" or file down the teeth by rasping any rough edges which may have developed on the grinders. This sharpness can cause pain and prevents the horse from chewing his food thoroughly. If you notice him dropping feed from his mouth while eating, this is a strong indication that his teeth need attention. The veterinarian may have to extract some "wolf" teeth which could interfere with the bit. This is a simple procedure, not requiring surgery or anesthesia (unlike humans).
Hoof Care
When choosing a farrier (blacksmith), it is imperative to select a reputable one, perhaps recommended by your veterinarian or other horse owners. There is much truth to the saying "no foot, no horse," and poor hoof care can take up to a year to repair. The horse's feet need trimming every 6-8 weeks, depending on growth rate, use, and environment. If you intend to ride on hard or rocky surfaces, the horse will need shoes to protect the hooves and keep them from cracking and breaking. Depending on the environment, it may be necessary to apply a dressing routinely to help keep the hooves from drying out.
General Management Recommendations
In horse management, the key word is PREVENTION. Here are some precautions to avoid a catastrophe:
FUTURE SCIENTIST INTERNS WITH CVM
Stephanie McQuilkin, a student at Magruder High School, Derwood, Maryland, is the recipient of the Claudio Cavazza Science Award which enabled her to spend six weeks with the Division of Animal Feeds in the Center for Veterinary Medicine (CVM). Sigma-tau Pharmaceuticals, Inc., of Gaithersburg, Maryland, is a U.S. subsidiary of Italy’s leading research-based pharmaceutical company, sigma-tau S.p.A., and sponsored this award in collaboration with the FDA and the Montgomery County Public School System. Initiated in 1996, the award promotes science as a career and provides high school students the opportunity to gain hands-on experience in a scientific work setting.
Hoping for a future career in biotechnology, Stephanie received unique training in that field as a student at the Thomas Edison High School for Technology during the 1997-98 school year. During her term at CVM, Stephanie was responsible for a number of projects. She focused on researching genes implanted in plants to identify their functions and applications. She also assisted in developing a white paper on the growing standards of soybeans. This report will serve as a resource on soybean growth for agricultural groups throughout the world. Dr. William D. Price served as Stephanie’s mentor at CVM.
Also active in sports, Stephanie hopes to find time for track and soccer activities while pursuing her studies in biotechnology.
WINDOWS TO RESEARCH AND REGULATORY SCIENCE INTERN PROGRAM
by Bessie M. Cook
The Center for Veterinary Medicine (CVM) EEO Office sponsors a scientific academic outreach program in collaboration with National Institutes of Health (NIH) and Foundation for Advanced Education in the Sciences (FAES) to provide training opportunities for undergraduate, graduate, and professional students. The program’s mission is to develop a foundation in biomedical and related regulatory-based research that is integrated with scientific principles applicable to biological product development and regulation. The program seeks to promote personal development and professional skills reflective of the students’ field of study, with the ultimate goal of pursuing careers significant to the Center.
This summer, CVM was fortunate to have four individuals participating in the 1998 Student Intern Program, each assigned to a CVM Research/Review Scientist. These scientific mentors are responsible for providing a work experience that is challenging and stimulating, and one that will broaden the student’s technical skills and educational experiences. Students must have a 3.5+ grade point average to qualify for the Intern Program. Scherise Mitchell is a Biology major at Morgan University. Ms. Mitchell worked with Dr. Michaela (Mika) Alweynse, Division of Animal Feeds, and studied the "Effect of the Rendering Process on the Chromosomal DNA in Transgenic Animals." Nicole Doyle was assigned to work with Dr. Henry Ekperigin, Division of Animal Feeds. Ms. Doyle is a Biology and Veterinary Medicine major at Tuskegee University, and researched "Organic Acids and Formaldehyde as Antimicrobial Food Additives." Lynette Willis is a graduate of Hampton University with a Master of Science in Biology. Her mentors were Dr. Warner (Jack) Caldwell, Division of Biometrics and Production Drugs, and Dr. Margaret (Peggy) Miller, Office of New Animal Drug Evaluation. Ms. Willis performed a "Retrospective Review of Human Food Safety Toxicology Studies." Haile Yancy is a Biology major at Jarvis Christian College, and worked with Dr. Michael Myers, Division of Animal Research. Mr. Yancy’s project was to develop the reverse-transcriptase polymerase chain reaction to measure cytokine mRNA transcripts in whole blood cultures, using blood obtained from domestic animals.
CVM has long been a supporter of summer intern programs, to promote youth, vigor, new ideas, and to carry out projects beneficial to both the Center’s mission and the students.
For further information about CVM’s "Windows to Research and Regulatory Science" Student Intern Program, please contact Mrs. Bessie M. Cook, 301-594-1792, Ms. Sandra A. Mathews, 301-594-0074, or Dr. Woodrow M. Knight, 301-827-0219.
STABILITY DRAFT GUIDANCE DOCUMENTS AVAILABLE
FDA is announcing the availability of three draft Guidance for Industry (GFI) documents entitled "Stability Testing of New Animal Drug Substances and Products" (#73), "Stability Testing for New Dosage Forms of New Animal Drugs" (#74), and "Stability Testing: Photostability Testing of New Animal Drug Substances and Products" (#75).
These draft documents have been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). They are intended to provide guidance on stability testing of new drug substances and products and new dosage forms included as part of registration applications for approval of veterinary medicinal products submitted for approval to the European Union, Japan, and the United States.
Copies of these documents may be obtained from CVM's Internet Home Page or by contacting the FDA Veterinarian.
In recent years, many important initiatives have been undertaken to promote the international harmonization of regulatory requirements. FDA has participated in VICH efforts to enhance harmonization and has expressed its commitment to seeking scientifically based harmonized technical requirements for the registration of pharmaceutical products. One of the goals of harmonization is to identify and reduce the differences in technical requirements for drug registration among regulatory agencies in different countries.
The draft guidance entitled "Stability Testing of New Animal Drug Substances and Products" addresses the generation of stability information that should be included in submissions for applications for registration or approval of new molecular entities and associated drug products. The guidance entitled "Stability Testing: Photostability Testing of New Animal Drug Substances and Products" sets out a basic testing protocol for photostability. "Stability Testing for New Dosage Forms of New Animal Drugs" addresses the generation of stability information for new dosage forms for submission by the owner of the original application for registration, after the original application for new drug substances and products has been submitted.
Further information about these draft guidance documents is contained in a July 30, 1998, Federal Register notice. Information on the draft guidance documents is also available from William G. Marnane, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-0678. E-mail: wmarnane@bangate.fda.gov. Further information on VICH is available from Dr. Sharon Thompson, Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1798. E-mail: sthompso@bangate.fda.gov.
FDA GUIDANCE ON BSE FEED REGULATION AVAILABLE
FDA’s Center for Veterinary Medicine (CVM) has released a guide intended to answer questions about "Animal Proteins Prohibited from Animal Feed", the BSE feed regulation. The guide, titled "Questions and Answers -- BSE Feed Regulation" (Guidance Document 76) is intended to supplement the Small Entity Compliance Guides for the regulation, specifically the following FDA Guidance for Industry documents:
67 - Renderers
68 - Protein Blenders, Feed Manufacturers, and Distributors
69 - Feeders of Ruminant Animals With On-Farm Feed Mixing Operations
70 - Feeders of Ruminant Animals Without On-Farm Feed Mixing Operations
FDA’s final rule (21 CFR 589.2000) became effective August 4, 1997, and prohibits the feeding of certain mammalian protein to ruminant animals. It is designed to prevent the establishment and amplification through feed of bovine spongiform encephalopathy (BSE) in the United States.
Recently, CVM cosponsored a national satellite teleconference to show feed mill managers how to comply with the BSE rule, and to help assure them that an FDA inspection would find their mill in compliance. Questions and answers from the teleconference will be available soon, and posted on CVM’s Internet Home Page, completely separate from this guidance document.
The guide is available through the CVM Internet Home Page or by contacting the FDA Veterinarian. Additional information regarding this document may be obtained by contacting Gloria Dunnavan, Center for Veterinary Medicine, Division of Compliance, HFV-230, 7500 Standish Place, Rockville, MD 20855, 301-594-1726.
FDA PUBLISHES LABELING RULES FOR ANIMAL DRUGS
In the June 17, 1998, Federal Register, FDA published a final rule on the labeling of drugs for use in milk-producing animals. This rule removes the existing 96-hour withdrawal time limitation, eliminates the requirement to calculate and label on the basis of the number of 12-hour milking periods that have elapsed since treatment, and permits a milk-discard or withdrawal time to be calculated by elapsed hours since treatment. FDA is taking these actions to allow greater flexibility in the labeling of these drugs which will make it easier and more economical for sponsors to comply with the regulations.
The previous 96-hour limitation was based on FDA’s perception that 96 hours constituted a maximum practical withdrawal time for the dairy industry. However, FDA now recognizes that a withdrawal time longer than 96 hours may be desirable and practical in certain circumstances. Removal of the 96-hour limitation will allow the possibility of a longer withdrawal time to be considered for milk-producing animals on a case-by-case basis depending on the use and safety of the drug.
Similarly, the 12-hour milking schedule was established to calculate the number of milkings that occur during the withdrawal period. The 12-hour milking interval was considered to be generally reflective of dairy practice when this regulation was published; however, alternative milking schedules, such as three times a day milking, are in common use in the dairy industry today. The new rules revise the regulation so that the length of the milk cycle is not specified, eliminating the reference to the milking interval as long as milk is discarded the assigned number of hours after the latest drug treatment.
Additional information about this rule is available in the Federal Register (Volume 63, Number 116, pp. 32978-32980) and from Dr. Steven D. Vaughn, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1620.
On August 19, CVM held a public meeting to solicit views on how the Center can best meet its statutory obligations.
Under Section 406(b) of the FDA Modernization Act (FDAMA) of 1997, the Agency is required to consult with its external stakeholders. Following these consultations, FDA is to develop and publish a plan for achieving compliance with each of its obligations under the Federal Food, Drug, and Cosmetic Act.
A total of 85 people attended the CVM meeting, which was held in Washington, DC. Fifteen (15) CVM stakeholders made formal presentations, and there were informal presentations by several others. Stakeholders making formal presentations included representatives from animal drug industry associations (such as the Animal Health Institute), veterinary medicine associations (such as the American Veterinary Medical Association), producer groups (such as the National Pork Producers Council), feed trade associations (such as the National Grain and Feed Association), animal science societies, State feed control officials, and consumer groups.
The stakeholders commented on various issues including implementation of the Animal Drug Availability Act (ADAA), antimicrobial resistance, the drug review process, CVM resources and priorities, user fees, third party review, enforcement, international activities, cooperation/collaboration between the Center and its stakeholders, science infrastructure, and field issues.
A transcript of this meeting may be requested in writing from the Freedom of Information Office (HFI-35), Food and Drug Administration, 5600 Fishers Lane, Room 12A-16, Rockville, MD 20857. The transcript also is included on the FDA Home Page (http://www.fda.gov/).
by Jerome J. McDonald, Ph.D.
FDA’s Office of Regulatory Affairs is engaged in a project to replace several database applications with one application called the Field Accomplishments and Compliance Tracking System, or FACTS. Version 1 of FACTS is now being installed at ORA headquarters and field offices. FACTS is designed to speed communication between ORA headquarters and field offices, and to enable FDA Centers to interact directly with field activities.
FACTS V1 automates a number of operational activities, including issuing and managing sample collection and analysis; sample collection records; sample tracking, accountability, and disposition; reporting of detailed laboratory analytical results for six types of analyses (pesticides colors, elements, mycotoxins, radionuclides, and food additives); reporting analysis summaries for all other sample types; and managing firm (OEI) and registration data. Centers will utilize FACTS V1 to issue sample collection requests to the Field offices, to monitor the completion status of analysis assignments, to enter/update firm and registration data, and to view/retrieve analytical results and other data in the system. FACTS Version 2 will be implemented in FY 1999 and will include inspections, investigations, recall effectiveness checks, compliance actions, and detailed analytical results for all other sample types.
FACTS V1 is currently being installed at CVM. Several of the Center’s personnel have been trained in its use and will be assisting new users in learning how to use FACTS. As soon as functional roles are assigned to CVM personnel, they will begin using FACTS V1 as a major tool to interact with the ORA field offices.
LAMPLEY ORDERED TO CORRECT PAST VIOLATIONS
On March 13, 1998, the Federal Court for the Eastern District of Pennsylvania found Mr. Frank Lampley from Glenmoore, Pennsylvania, to be in indirect contempt of a 1992 permanent injunction order. The original order prohibited Mr. Lampley from distributing adulterated or misbranded animal drugs in interstate commerce. The Court ruled that Mr. Lampley had continued to promote and sell unapproved new animal drugs such as "Formula S," "External Rub," "Vitamix," "Formula M," and "Mineral and Protein Mix," in spite of the 1992 injunction.
Mr. Lampley failed to appear for a follow-up court hearing scheduled for May 26, 1998, while continuing to advertise and promote his unapproved new animal drug products. On June 25, 1998, the United States District Court for the Eastern District of Pennsylvania entered an order requiring Mr. Lampley to cure his past violations by July 31, 1998, including sending a notification, drafted verbatim by the Court, to all his past customers since June 19, 1992, that his drugs contained claims that FDA found to be not approved; providing a certification to the court as to which persons he notified; and withdrawing and destroying all past advertising and promotion. The Court has ordered that Mr. Lampley submit a draft copy of this customer letter to the Court for consideration by close of business July 6, 1998. In addition, Mr. Lampley must submit evidence that he has taken all necessary measures to withdraw the advertising and promotional material that directly, or indirectly promotes, advertises, or suggests that any of his products can diagnose, cure, mitigate, treat, prevent, aid in the treatment of disease in animals, or affect the structure or function of the bodies of animals. Mr. Lampley was ordered to destroy by July 24, 1998, all existing labeling, advertising, and promotional material for such products.
The Food and Drug Administration may conduct an inspection of Mr. Lampley’s premises after July 31, 1998, to determine his compliance with the Court Order.
In the event that Mr. Lampley fails to comply with any part of the order he would be subject to a fine in the amount of $500 per day, beginning on August 3, 1998.
This case involved a joint effort by FDA’s Office of General Counsel, Office of Regulatory Affairs, Philadelphia District Office, and the Center for Veterinary Medicine.
REGULATORY ACTIVITIES
The following firms/individuals received warning letters for offering animals for slaughter that contained illegal drug residues:
o Antonio D. Carvalho, Riverdale, CA
o James Myer, Lititz, PA
o Andrew J. Ormonde, A.T.O. Dairy, Riverdale, CA
o Frank Borba, Escalon, CA
These violations involved illegal residues of gentamicin in a cow; tilmicosin in a cow; sulfadimethoxine in a dairy cow; and gentamicin, penicillin, and sulfadimethoxine in a cow.
Warning letters were sent to the following firms/individuals for violations from Good Manufacturing Practices (GMPs):
o J. Gordon Dixon, President, Animal Repellants Inc. (ARI), Orchard Hill, GA
o Mike Reed, President and CEO, PM Ag Products, Inc., Homewood, IL
A warning letter was sent to Joe Edge, Co-Owner, Aubrey/Pilot Professional Products, Pilot Point, TX, for the sale and promotion of veterinary drugs which were adulterated and misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act.
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| Alpharma Inc. (NADA 141-100) |
Bacitracin Methylene Disalicylate, Decoquinate, Roxarsone (BMD, Deccox, 3-Nitro) | Broiler chickens. To be used as an aid in the prevention of necrotic enteritis, for the prevention of coccidiosis, and for increased rate of weight gain, improved feed efficiency, and improved pigmentation. |
MEDICATED FEED: Roxarsone is a Category II drug. Formerly, a Medicated Feed Application (MFA) was required for feed mills to make Type C medicated feeds using Category II Type A medicated articles. Following passage of ADAA, a feed mill license is required. The feed is to be fed as sole ration and NOT fed to layers or breeders. It is to be withdrawn 5 days before slaughter. Access to drinking water should be provided at all times. Federal Register 7/17/98. |
| Alpharma Inc. (NADA 141-085) |
Bacitracin Methylene Disalicylate, Zoalene (BMD, Zoamix) | Turkeys. To be used for prevention and control of coccidiosis, and for increased rate of weight gain and improved feed efficiency. |
MEDICATED FEED: For turkeys grown for meat purposes only, not to be fed to laying birds. Fed as sole ration until 14 to 16 weeks of age. Federal Register 7/20/98. |
| Alpharma Inc. (NADA 141-088) |
Bacitracin Methylene and Nitarsone (BMD, Histostat) | Turkeys. To be used as an aid in the prevention of blackhead and for increased rate of weight gain and improved feed efficiency. | MEDICATED FEED: For growing turkeys as sole ration. Adequate water must be provided near feeders at all times. Overdosage or lack of water may result in leg weakness or paralysis. Use to be discontinued 5 days before slaughter. Drug is dangerous for geese, ducks, and dogs. Federal Register 7/21/98 |
| Pharmacia & Upjohn (NADA 46-718) |
Melengestrol Acetate (dry form) (MGA) and Oxytetracycline (dry form) (OTC) |
Confined heifers. For increased rate of weight gain, improved feed efficiency, suppression of estrus, and reduced incidence of liver abscesses. | MEDICATED FEED: Only for heifers fed in confinement. Feed containing MGA 0.25 to 0.5 milligrams per head per day and 75 milligrams oxytetracycline per head per day. Do not mix liquid MGA with liquid oxytetracycline in a common liquid feed supplement. Federal Register 8/3/98. |
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Pharmacia & Upjohn (NADA 46-719) |
Melengestrol Acetate (MGA) (liquid form) and Oxytetracycline (dry form) (OTC) | Confined heifers. For increased rate of weight gain, improved feed efficiency, suppression of estrus, and reduced incidence of liver abscesses. | MEDICATED FEED: Only for heifers fed in confinement. Feed containing MGA 0.25 to 0.5 milligrams per head per day and 75 milligrams oxytetracycline per head per day. Federal Register 8/3/98. |
| Boehringer Ingelheim Animal Health, Inc. (NADA 140-973) | Clenbuterol HCl Syrup Rx (VENTIPULMIN) | Horses. For the management of horses affected with airway obstruction such as occurs in chronic obstructive pulmonary disease(COPD). | ORAL: Administer twice a day. Treat at effective dose for 30 days. The effect on breeding stallions and brood mares has not been determined. At end of 30 day treatment period drug should be withdrawn. Federal law prohibits the extra-label use of this drug in food animals. Federal Register 8/4/98. |
ABBREVIATED NEW ANIMAL DRUG APPROVALS
| Company | Generic and (Brand) Names | Indications | Routes/Remarks |
| Med-Pharmex, Inc. (ANADA 200-229) | Gentamicin Sulfate, Betamethasone Valerate, and Clotrimazole. (Tri-Otic ointment) | Dogs. For treatment of acute and chronic otitis externa associated with yeast and/or bacteria susceptible to gentamicin. | TOPICAL: ANADA is a generic copy of Schering-Plough Animal Health Corp. NADA 140-896. (OTOMAX) Federal Register 6/11/98. |
Phoenix Scientific, Inc. (ANADA 200-202) |
Ivermectin Oral Liquid (Phoenectin Liquid) Rx | Horses. For treatment and control of parasites and parasitic conditions | ORAL: ANADA is a generic copy of Merial Ltd.’s NADA 140-439 (Eqvalan liquid). Federal Register 7/17/98. |
Phoenix Scientific, Inc. (ANADA 200-246) |
Pyrantel Pamoate Suspension | Horses and ponies. For removal and control of mature infections of large & small strongyles, pinworms, large round-worms. |
ORAL: ANADA is a generic copy of Pfizer, Inc.’s NADA 91-739 (Strongid T). Federal Register 7/24/98 |
G.C. Hanford Manufacturing Co. (ANADA 200-180) |
Ampicillin Trihydrate Sterile Powder Rx | Cats, dogs, cattle and calves including veal. For treatment of respiratory, skin, urinary tract, gastrointestinal, soft-tissue, and postsurgical infections of dogs and cats, and intramuscular use for the treatment respiratory infections in cattle and calves. |
SUBCUTANEOUS or INTRAMUSCULAR: ANADA 200-180 is a generic copy of Fort Dodge Animal Health’s NADA 55-030 (Polyflex). Federal Register 8/4/98. |
SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS
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Generic and (Brand) Names |
Indications |
Routes/Remarks |
| Hoechst Roussel (NADA 120-648) | Fenbendazole Paste (Panacur) (Safe-Guard) | Horses. For treatment of encysted mucosal cyanthostome larvae including early and late third stage, and fourth stage larvae.
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ORAL: The supplemental NADA provides for expanding the indications to include additional organisms. Federal Register 6/10/98. |
Alpharma Inc. (NADA 46-666) |
Penicillin G Procaine | Chickens, turkeys, pheasants, quail, swine. For improved feed efficiency and increased rate of weight gain. | MEDICATED FEED: The supplemental NADA reflects the results of the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Implementation (DESI) review of the product’s effectiveness and FDA’s conclusions based on that review. Federal Register 7/2/98.
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| Pfizer, Inc. (NADA 46-668) | Penicillin G Procaine | Chickens, turkeys, pheasants, quail, swine. For improved feed efficiency and increased rate of weight gain. | MEDICATED FEED: The supplemental NADA reflects the results of the National Academy of Sciences/National Research Council (NAS/NRC) Drug Efficacy Study Implementation (DESI) review of the product’s effectiveness and FDA’s conclusions based on that review. Federal Register 7/2/98. |
| Western Chemical, Inc. (NADA 140-989) | Formalin (Parasite-S) | Finfish and finfish eggs. Provides for use of formalin in solution as a parasiticide in water of all finfish and a fungicide in water of all finfish eggs. |
TOPICAL: The supplement broadens the scope of the NADA from select fish and select fish eggs to all finfish and all finfish eggs. Federal Register 7/16/98. |
| Alpharma, Inc. (NADA 65-470) | Bacitracin Methylene Disalicylate (BMD Soluble) | Quail. To make a medicated drinking water for growing quail for prevention of ulcerative enteritis. |
DRINKING WATER: Used as sole source of drinking water, containing 400 milligrams of bacitracin per gallon. Federal Register 7/17/98. |
| Schering-Plough Animal Health Corp. (NADA 101-479) | Flunixin Meglumine (Banamine Inj. Sol.) Rx | Beef cattle and non-lactating dairy cattle. For the control of pyrexia associated with bovine respiratory disease & endotoxemia, and control of the inflammation in endotoxemia. | INTRAVENOUSLY or INTRAMUSCULARLY: The supplement adds use in certain cattle in addition to use in horses. In addition, a tolerance of 0.125 ppm in cattle liver and 0.025 ppm in muscle are established. An ADI of 0.72 micrograms per kilogram of body weight per day is also established. Federal Register 7/20/98. |
| Alpharma Inc. (NADA 46-592) | Bacitracin Methylene Disalicylate (BMD) | Replacement chickens. To be fed as an aid in the prevention and control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to BMD. |
MEDICATED FEED: The supplement adds new use in replacement chickens. Federal Register 7/31/98. |
| Schering-Plough Animal Health Corp. (NADA 141-063) | Florfenicol Injection (Nuflor) Rx | Cattle. For treatment of bovine respiratory disease. | SUBCUTANEOUS: The supplement provides for the new route, a new dosage of 40 milligrams per kilogram body weight and a 38-day slaughter withdrawal time and a tolerance of 3.7 ppm for florfenicol amine in liver and 0.3 ppm in muscle. An ADI of 10 micrograms per kilogram body weight per day is also established. Federal Register 8/3/98. |
| Novartis Animal Health US, Inc. (NADA 141-084) | Milbemycin Oxime/Lufenuron Tablets (Sentinel) Rx | Dogs. For prevention and control of flea populations and prevention of heartworm disease, for control of hookworm, and for removal and control of adult roundworm and whipworm infections. | ORAL: The supplement provides for use for dogs not less than 4 weeks of age and not less than 11 pounds of body weight. This new formulation qualifies for 3 years of marketing exclusivity. The tablets are administered once a month. Use a minimum of 0.5 milligram of milbemycin and 10 milligrams of lufenuron per kilogram of body weight. Federal Register 8/3/98. |
| Novartis Animal Health US, Inc. (NADA 140-915 | Milbemycin Oxime Tablets (SAFEHEART) Rx
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Dogs. For the prevention of heartworm disease caused by Dirofilaria immitis at a minimum dosage of 0.05 mg/lb. of body weight. | ORAL: The supplement provides for use of a lower dose of milbemycin in treating dogs and puppies. A dose of 2.3 and 5.75 mg tablets monthly in dogs 4 weeks of age or older and 2 pounds or greater body weight. Do not use in puppies less than 4 weeks of age or less than 2 pounds body weight. Federal Register 8/3/98. |
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