1/ Includes Salaries & Expenses, Rent, and PDUFA, where applicable.

EXPLANATION OF PROGRAM

American consumers rely on the FDA to improve health by ensuring that safe and effective medicines are available and that unsafe or ineffective drugs stay off the market, and to ensure clear, unbiased easily understandable drug information is available to prescriber, patients and consumers.

Before new drugs can be marketed in the United States, they must undergo an independent review by FDA scientists. If the review establishes that a drug is both safe and effective it is approved for marketing. In addition to prescription drugs, FDA reviews and regulates over-the-counter drugs and the generic counterparts of prescription and over-the-counter drugs and drugs designated as Orphan Drugs.

Neither FDA nor the industry can learn everything about the safety of a drug before it is approved. Continued vigilance by FDA is required after a drug is approved. This includes monitoring the quality and safety of manufacturing products, regulating the advertising and promotion of prescription drugs, ongoing surveillance for adverse events and use problems, and promoting informational and educational programs that address both medical and consumer interests.

The Office of Orphan Products Development (OOPD) Program promotes the development of products that demonstrate promise for the diagnosis and/or treatment of rare diseases or conditions. To locate such products, the OOPD interacts with the medical and research communities, professional organizations, academia, and the pharmaceutical industry, as well as rare disease groups. The OOPD administers the major provisions of the Orphan Drug Act (ODA) which provide incentives for sponsors to develop products for rare diseases. The program began in 1983 and has seen the approval of drugs for diseases such a pulmonary hypertension in the newborn, hairy cell leukemia, severe combined immunodeficiency syndrome (SCIDS), and many more rare and most often life-threatening diseases.

FY 2001 BUDGET REQUEST

ASSURING SAFETY/STRENGTHENING SCIENCE INITIATIVES

PREMARKET INITIATIVES + $2.3 MILLION, 3 FTE

Bringing Products of New Technology to Market + $2.3 million, 3 FTE

Limited scientific knowledge delays health and safety benefits and may lead to over-regulation because of inadequate understanding of the risks involved. Requested resources will be used to improve the premarket review process through:

• Research to identify, monitor and minimize drug toxicity and adverse drug reactions.
• Leveraging increased scientific capability and support from external stakeholders having appropriate medical and scientific expertise.

POSTMARKET INITIATIVES + $19.5 MILLION, 119 FTE

Internet Drug Sales + $9.7 million, 75 FTE

Over the past couple of years, FDA has become aware of fraudulent activities involved with the sale of approved and unapproved prescription drugs over the Internet. The Agency is deeply concerned about maintaining the integrity of drug sales within the United States. The requested increase would allow FDA to:

• Conduct undercover online purchases of prescription drugs from Internet sites suspected of engaging in illicit drug sales, distribution, and/or marketing.
• Utilize laboratory personnel and resources for analytical testing of prescription drugs purchased over the Internet in order to determine if products are misbranded or counterfeit.
• Reduce the fraudulent distribution and sale of unapproved, misbranded, and possible counterfeit prescription drugs to consumers.
• Reduce the sale of prescription drugs to consumers by those Internet sites that do not require a legitimate prescription.
• Reduce the practice of Internet online diagnosis, where a doctor and pharmacy affiliated with an Internet website provide prescription drugs based only on the review by a doctor of an online medical questionnaire completed by the consumer. Without appropriate medical supervision of their medication, consumers are at an increased health risk.
• Reduce the health risks to individuals ordering pharmaceuticals from foreign sources over the Internet by providing oversight of mail and courier packages entering from foreign sources and destined for individuals, e.g., personal importations. These personal importations are largely excluded from FDA's electronic import data system (OASIS).

Reduce the illegal promotion, sales, and distribution of approved and unapproved prescription and non-prescription pharmaceuticals via the Internet. Protect consumers from obtaining unsafe, ineffective, and fraudulent products that present a real danger to the public health. ²

Medical Errors + $6.0 million, 13 FTE

The Institute of Medicine's (IOM) 1999 report on medical errors emphasized the need for the American medical community to reevaluate practices and procedures that may lead to fewer deaths. Additional resources of $6 million in this area will be used in FY 2001 to do the following:

• Complete FDA's new on-line adverse event reporting system (AERS) for drugs and biologics, to provide rapid assessment of injuries and deaths associated with the use of these products. (Human Drugs Performance Goal # 8)
• Additional staff to increase attention to drug naming, packaging and labeling. Approximately 50 percent of reported medication errors are related to the naming, labeling and/or packaging of the product.
• Develop linkages to government and private health care data sources. This access to broad-based health information databases allows for more rapid exploration of potentially serious drug-related problems and for more rigorous investigations than are currently possible. As a result, fewer lives are lost or injuries incurred before action is taken.
• Expand educational programs for health care providers and the public to promote the safe use of products (publications, dissemination of information to the public). (Human Drugs Performance Goal # 12)
• Provide training for field staff to improve the information gathered through investigation of consumer complaints and upgrade field data systems to provide consumer complaint data that complements AERS.

² We have attempted to align the budget request and performance plan goals. All italicized items represent performance goals in the Agency's performance plan, with the specific reference following. More information on these goals and past performance can be found in the performance plan. Inspectional Activities + $3.8 million, 31 FTE

FDA will increase the inspectional coverage rate of both domestic and foreign establishments while the overall inventory continues to expand. The request for $3.8 million for inspectional activities will be used to:  

• Improve the confidence that FDA has in the safety of foreign drug products by implementing the European Mutual Recognition Agreement and by intensifying drug inspections in developing countries.
• Improve FDA's ability to evaluate and target high risk imported bulk drug and finished drug products by developing automated reports on drug imports. 
• Develop pilot inspection contracts in the area of medical gas manufacturing and other leveraging strategies, that will enable FDA to meet its statutory inspection obligation while focusing on risks in drug products. (Human Drugs Performance Goal # 10)
• Expand the ability of federal, State and local partnerships to improve drug safety by expanding the ability of FDA's partners to share data through the field data systems.
• Enhance the field data systems to provide summary data and automated analyses to support FDA's regulatory initiatives, identify high-risk products and foreign sources, and allow real time data sharing on adverse events so that FDA can make more effective and efficient use of resources.  
• Recruit, hire and train new investigators and provide training, information technology and contract support to improve the scientific expertise of field investigators thus enabling them to conduct the premarket inspections that are essential to meet premarket review time frames.  
• Replace outdated field laboratory drug analysis equipment with modern equipment to improve the accuracy and timeliness of drug product analyses to determine compliance with safety requirements.
• Establish Quality Management System procedures as a normal part of all field drug program activities to increase consistency and quality of field drug activities nationwide.

USER FEES

PREMARKET

Current Law User Fees +$2.2 million

Prescription Drug User Fee Act II (PDUFA II) + $ 2.25 million

FDA proposes to revise the distribution of projected spending of PDUFA fees for FY 2001 among the Human Drugs, Biologics, and Other Activities programs to reflect recent patterns of actual spending within the PDUFA program. This is similar to reallocations approved by the Appropriations Committees in both FY 1998 and FY 1999, and will not increase FDA's total spending for Other Activities. The net change for this reallocation is zero.

The reallocation within PDUFA is necessary to assure that PDUFA fee revenues are used to pay their fair share of the costs of FDA management (Other Activities). To make this change permanent, our FY 2001 budget request reflects our proposal to fully utilize these funds for Other Activities and possibly avoid a reprogramming later in the year. This $5 million of Salaries and Expenses funds will be made available to FDA operating programs (excluding Tobacco), as a partial alleviation of the cost impact of the recent 4.8 percent general pay raise.

The total PDUFA budget request for the Agency in FY 2001 is $149.27 million and 920 FTE, including $99.3 million and 620 FTE for the Human Drugs program. As a result of the proposal to reallocate PDUFA funds, the program will experience a decrease of $3.5 million, the difference between the $5.7 million reallocation from the Human Drugs program and a $2.245 million increase in inflationary costs. The user fees have enabled FDA to improve its performance for drug review and approval times. In FY 1991, the median approval time for human drug applications was 21 months. For all open cohorts during FY 1999, the Human Drugs program took 185 actions on New Drug Applications (NDA), 77 of which were approvals and the median approval time was 11.9 months. The fees collected in FY 2001 will enable the FDA to continue to meet its PDUFA II performance goals, which include the following:

• Review and act on 90 percent of standard original NDA and PLA/BLA submissions filed during FY 2001 within 12 months of receipt, and review and act on 70 percent within 10 months of receipt.
• Review and act on 90 percent of priority original NDA and PLA/BLA submissions filed during FY 2001 within 6 months of receipt. 
• Review and act on 90 percent of standard efficacy supplements filed during FY 2001 within 12 months of receipt, and review and act on 70 percent within 10 months of receipt. 
• Review and act on 90 percent of priority efficacy supplements filed during FY 2001 within 6 months of receipt. 
• Review and act on 90 percent of manufacturing supplements filed during FY 2001 within 6 months of receipt and review and act on 70 percent of manufacturing supplements requiring prior approval within 4 months of receipt. 
• Review and act on 90 percent of Class 1 resubmitted original applications filed during FY 2001 within 4 months of receipt, and review and act on 70 percent within 2 months of receipt. 
• Review and act on 90 percent of Class 2 resubmitted original applications filed within 6 months of receipt.

SPECIAL PROGRAM INITIATIVES

Countering Bioterrorism + $1.2 million, 3 FTE

FDA plays a critical role in the preparation for bioterrorist attacks by reviewing new drugs and drugs used in combination with other types of products to counter the effects of anthrax and other potential bioterrorism events. The Agency must also conduct Good Manufacturing Practice inspections of drug manufacturers whose products may be stockpiled as a part of the government's bioterrorist efforts. As part of the interagency effort FDA intends to:

• Participate in the planning and coordination of public health responses to bioterrorist attacks.
• Prepare field staff to safely seize, remove, and dispose of contaminated products by developing procedures and providing appropriate facilities and equipment. Develop inspection methods and procedures to assure the safety of regulated products at manufacturers and other establishments.

JUSTIFICATION OF BASE

The Human Drugs Program focuses on several primary initiatives that include meeting the mandates of the Food and Drug Modernization Act, the goals of the Prescription Drugs User Fee Act, continuing the Orphan Drug Program, and initiatives such as pediatric labeling that have a major impact on the public health. A brief description of base activities include:

• Regulate the testing of investigational new drugs (IND review), and evaluate new drug applications (NDAs) received from sponsors. (Human Drugs Performance Goal # 1)
• Support an active generic drugs program (ANDA review) with a focus on expanding the availability of high quality generic drug products to the public. (Human Drugs Performance Goal # 3) 
• Review over-the-counter (OTC) drugs to ensure safety and effectiveness and to help consumers understand how to best use OTC products. 
• Collect, evaluate, and act upon information on adverse events associated with marketed products. 
• Ensure that the highest possible quality products are marketed by focusing on product quality standards and the compliance of manufacturers with standards established in the good manufacturing practices (GMP) regulations. 
• Expand scientific capabilities to respond and contribute to major breakthroughs in pharmaceutical research and technology via research, continuing professional development and training, and continued collaborations with stakeholders. (Human Drugs Performance Goal # 9) 
• Disseminate timely and accurate product information to the medical community and the public. (Human Drugs Performance Goal # 12) 
• Focus on projects of special importance such as pediatric labeling, risk management and education and outreach. 
• Continue the pilot program for research and training for clinical pharmacologists. Agency will award cooperative agreements to support post-doctoral training and research to study clinical pharmacology and biopharmaceutics issues related to new drug development and review.  
• FDA continues to carry out a program encouraging the development of drugs, biologicals, medical devices and medical foods for rare diseases and conditions.Office of Orphan Products Development (OPD) staff meets with potential sponsors of orphan products to provide guidance on the development of these products as well as guidance on orphan product "designation" applications and issues. OPD also participates in internal FDA sessions and FDA meetings with sponsors about ongoing development of orphan products. In FY 1999, OOPD awarded new grants to 23 health and medical institutions for the study of rare diseases and conditions. The combination of new and reissued grant awards totaled $11.25 million. FDA anticipates a significant increase in the overall interest in the program in FYs 2000 and 2001, as well as more informational meetings, applications, and designation reviews. 
• Increased program interest and activity results from recent Congressional initiatives which enhance the value of orphan designation. Renewal of the Federal tax credit associated with orphan product designation, establishing it with a "carry-back/carry forward" eligibility, and making it permanent, is one factor. Another is an exemption from the marketing application user fees for these designated products incorporated in the renewal of the agency's prescription drug user fee authority.

Human Drugs

Selected FY 1999 Accomplishments

FOOD AND DRUG MODERNIZATION ACT OF 1997 (FDAMA):

• Pediatric Exclusivity.  Published an annual list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. Granted pediatric exclusivity to seven products. Developed interactive pediatric web page at http://www.fda.gov/cder/pediatric to provide detailed information to the public regarding FDA's pediatric initiatives.
• OTC Sunscreen Products. Published the final rule for OTC sunscreen UVB drug products for the prevention of sunburn. 
• Fast Track Designation. Expedited the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. FDA approved two products under Fast Track for the treatment of HIV: Zioagen and Agenerase.  
• Pharmacy Compounding.  Created a special exemption to ensure continued availability of compounded drug products prepared by pharmacists to provide patients with individualized therapies not available commercially.

PREMARKET REVIEW

Prescription Drug User Fee Act of 1992 (PDUFA). Exceeded the progressively more stringent PDUFA performance goals for each successive fiscal year under PDUFA, despite unexpected, continued growth in the number of applications for original new drug applications (NDAs), resubmissions of original NDAs, efficacy supplements and manufacturing supplements to already approved marketing applications. PDUFA is a proven success for the industry, FDA, and consumers.

New Drug Evaluations. Took 185 actions on New Drug Applications (NDAs), 77 of which were approvals. The median approval time was 11.9 months, a one percent decrease in median approval time compared with FY 1998. Forty-nine of these NDAs were approved in 12 months or less. Of these 77 approvals, 27 were for new molecular entities (NMEs) - drugs that are chemically different in structure from those already on the market. The median approval time for NMEs was 9.0 months, a 25 percent decrease compared with FY 1998. Of the 27 NMEs, 19 were drugs given a priority review (products offering a significant improvement over currently marketed drugs). 

NDAs and Supplemental NDA Approved for Accelerated Approval in FY 1999

Approved 37 priority applications (19 NMEs, nine NDAs that were not NMEs, and 9 efficacy supplements).

Pharmacology/Toxicology. Improved guidance to conduct and evaluate modern toxicological programs that support rapidly progressing clinical trials and drug reviews. To speed the drug development process, FDA reviewed 56 carcinogenicity protocols for studies prior to their initiation. FDA is involved in a number of collaborative efforts with academia, industry and the international community to evaluate the development and incorporation of new toxicological methods, both nationally and internationally.

Extended into two clinical pharmacology cooperative agreements with the University of Illinois at Urbana Champaign ($369,100) and with Meharry Medical College ($130,900).

Cancer. Successful implementation of the four initiatives from, "Reinventing the Regulation of Cancer Drugs" (released in 1996). The first initiative shortened approval times for cancer therapies by expanding the use of the accelerated approval mechanism. FDA approved three therapies under this mechanism in FY 1999. The second initiative expanded access of investigational agents to ensure that cancer patients in the US have access to potentially beneficial treatments approved by recognized foreign regulatory authorities, but are not yet marketed in the US. FDA found that few drug products approved outside of the US are considered similar or superior to those approved in the US. The third initiative included cancer patients in the review process. All FDA cancer therapy advisory committee meetings of the Oncologic Drugs Advisory Committee (ODAC) include an ad hoc member who has personal experience with the illness for which a product is being considered. The fourth initiative clarified regulations for exempting a marketed drug product from the requirements for an Investigational New Drug application (IND) when the drug is undergoing clinical testing in an unlabeled indication.

Over-the-Counter (OTC) Drug Products. Approved five new drug products and/or new indications for OTC marketing - Lamisil Cream (topical antifungal), Tagamet HB suspension (heartburn), and Pepsid AC Gelcap (heartburn), Zantac 75 Efferdose Tablet for the prevention of heartburn, and Children's Motrin Suspension for use in children six months to two years of age.

Fourteen monograph-rule making documents were published in the Federal Register, including the final rule for: alcohol warnings on anti-pyretic/analgesic products; professional labeling for aspirin, buffered aspirin, and aspirin in combination with antacid drug products; and the final rule for OTC stimulant laxative products to establish that the ingredients danthron and phenolphthalein are not generally recognized as safe and effective.

Pregnancy Labeling. Improved the current system of labeling products to make it more comprehensive and clinically meaningful by integrating input from multiple government agencies, consumer groups, medical experts, and the pharmaceutical industry.

Antibiotic Resistance. Addressed the growing problem of antibiotic resistance and its effects on drug development and regulation. Interacted with CDC on resistance activities, and NIH on developing a research plan to address the emergence of glycopeptide resistance in Staphylococcus aureus. Developed approaches to provide education on the problem of antibiotic resistance and to provide information on the appropriate use of antibiotics to health care professionals and to consumers. Developed statements to be added to antibacterial labels on antimicrobial resistance and the use of these products.

Bioterrorism. Developed regulatory policy options for stockpiling and using drug products that may be needed to respond effectively in the event of the deployment of biological weapons. Developed options for the resolution of issues; provided information on the regulatory status of various antibiotics for use against likely biological weapons; evaluated and recommended options for making unapproved products available; and provided recommendations for responding to a Department of Defense inquiry on stockpiling drug products. FDA is pursuing a collaborative relationship with the Centers for Disease Control to mutually facilitate the use of the IND mechanism for the distribution of unapproved products. This includes marketed products that are recognized by experts as the agent of choice for treatment or prophylaxis of infection following exposure to causative organisms for which the products are not approved.

Generic Drug Review. With the additional $1.0 million added to this program, approved 198 abbreviated new drug applications (ANDAs), 40 of which represent the first time a generic drug was available for the brand name product. Examples of first time approvals include: (1) Ranitidine tablets (over the counter), an H2 receptor histamine antagonist used in the treatment of ulcers (generic for Zantac 75 by Glaxo Wellcome), (2) Nicotine gum, an over-the-counter smoking deterrent (generic for Nicorette by SmithKline Beecham), (3) Cyclosporine oral solution, an agent used in prophylaxis of organ transplant rejection (generic for Neoral by Sandoz), and (4) Terazosin capsules, used for hypertension and benign prostatic hyperplasia (generic for Hytrin by Abbott Laboratories).

Issued tentative approval to 68 ANDAs. A tentative approval is issued to ANDAs awaiting expiration of patent(s) on a brand name drug. Examples of these tentative approvals include (1) Lovastatin tablets, a cholesterol lowering agent (generic for Mevacor by Merck & Co., Inc.), (2) Midazolam injection, an anesthetic agent (generic for Versed by Roche and (3) Fluoxetine capsules, an anti-depressant (generic for Prozac by Eli Lilly).

Decreased the number of review cycles from 2.7 to 2.4 cycles needed to approve abbreviated applications, as a result of FDA's initiative to contact applicants that undergo two or more major deficiency cycles.

SURVEILLANCE

Adverse Event Reporting System (AERS). Received approximately 261,000 individual safety reports (ISR) into AERS. FDA evaluates this spontaneous reporting data from AERS to identify any serious, rare, or unexpected adverse events or an increased incidence of events.

Establishment Inspections. Conducted 773 domestic establishment evaluations for Good Manufacturing Practices compliance in support of New Drug Applications. An additional 1,775 domestic establishment evaluations were conducted in support of ANDAs. Over 200 foreign establishment inspection reports (EIRs) were reviewed. The majority were in support of NDAs or ANDAs and covered the production processes including testing of an active pharmaceutical ingredient.

Recall and Drug Shortages. Recalled over 400 drugs, 16 of which were classified as Class I. (A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death). Managed 10 drug shortage situations to assure the availability of medically necessary drug products to treat serious life threatening diseases, e.g., myasthenia gravis, tuberculosis, AIDS and cancer.

RESEARCH

The Product Quality Research Initiative (PQRI). Began PQRI to conduct collaborative research with scientists from academia, industry, and FDA in the areas of pharmaceutical chemistry, biopharmaceutics, and science management to identify better test methods for assessing quality of products, identify optimal manufacturing and management processes. This collaboration will enable consistent and reasonable requirements for all product quality information submitted in a regulatory filing and will streamline the drug development and approval processes for industry and FDA.

Improved communication with consumers and patients through seminars on new drug therapies and labeling; brochures for consumer and patient use; information available via the Internet; programs to make promising investigational drugs, and therapies available to patients with serious and life-threatening diseases; assuring that patient representatives are included on advisory committees considering products for HIV/AIDS, cancer and other serious diseases; and disseminating information about new and existing products.

Developed easy to read, user-friendly information for consumer in partnership with the American Pharmaceutical Association, the National Consumers League, and the National Council on Patient Information and Education. Provided consumer focused information on new and innovative drugs approvals via a new drug page at www.fda.gov/cder/consumer info/default.htm. Implemented public information campaigns, including the dangers of GHB and GBL, Y2k and Medicines, and Over-the Counter Labeling.

Expanded the pharmacist education outreach program to help pharmacists better explain the drug approval process to consumers. Updated the publication: From Test Tube to Patient: New Drug Development in the US (www.fda.gov/fdac/special/newdrug/ndd_toc.html) which describes the drug development process in lay terms for the public.

Electronic Submissions. Expanded Electronic Document Room was expanded to manage the receipt and handling of full electronic NDAs. Conducted workshops to assist industry in preparing their electronic submissions, and classes were held for FDA reviewers to train them on how to use the electronic documents. FDA received 36 NDAs that included some electronic components and nine full electronic NDAs.

Expanded the electronic document management system (EDMS). Approximately 47,000 review documents have been filed using the system which gives reviewers the capability to electronically capture, sign, and archive their regulatory review products. The Agency also completed a requirements analysis and product evaluation and conducted a pilot for a new electronic document query capability that will allow reviewers to access any electronic document directly from the desktop. These activities should help reduce review times.

Enforcement Initiatives: Enforcement Actions - Reviewed legal or administrative enforcement actions initiated by the Agency to protect consumers by removing violative products from commerce or to obtain compliance with the law. These included:

Recall and seizures. Monitored 3,756 product recalls and seizure of 25 products. As a result, numerous violative, potentially harmful products never reached consumers.

• Mass Seizures in New York and Arizona of approximately $50 million worth of sterile injectable drug products manufactured by Steris Laboratories, Inc., and distributed by its parent corporation, Schein Pharmaceutical, Inc. This protected consumers from products manufactured under conditions that failed to assure their sterility.
• Warning Letters.  Sent approximately 900 to firms/individuals, with most achieving correction without further regulatory action. 
• Gamma butyrolactone (GBL) enforcement actions prevented potentially hazardous products from reaching consumers. Regulated the marketing of Gamma butyrolactone (GBL), a product that is a precursor to the potent unapproved drug, Gamma Hydroxybutyrate (GHB). Seized product at two GBL distributors. 

New Import Alerts in 1999 covered food, drugs (animal and human), biologic, medical device, radiation emitting devices, and cosmetic products. Examples include: bacterial contamination in mouth rinse (IA 53-20); neo-natal kidney cells (IA 57-13); allergy patches (IA 57-15); and non-sterile plastic bandages (IA 79-01).

Import Automation: Enhanced the Operational and Administrative System for Import Support, (OASIS) to allow screening of electronic import entries for attributes previously not possible using the U.S. Customs ACS system.

Inspectional Initiatives:

• EU Mutual Recognition Agreement (MRA): Participated in workgroups to review laws and regulations of the European Union, and to develop inspection report formats. Planned on-site assessments of the inspection programs and processes in the member states of the EU for the pharmaceutical annex for FY 2000.
• International Inspection Program Expanded: Completed almost 900 inspections of manufacturers of human pharmaceuticals, veterinary pharmaceuticals, high risk foods including seafood, medical devices including TVS, microwaves, computer monitors, and military blood bank and military MQSA facilities.

Orphan Drugs Program

• Approved the 200th designated orphan product, a milestone for FDA's Orphan Product Program, which treats more than 10 million patients in the United States.
• Reviewed 94 new sponsor requests for designation of drugs as orphan products. As part of the request for designation, sponsors are required to submit data that adequately demonstrates the use of their product for diseases or conditions affecting fewer than 200,000 people in the US, or that it meets economic qualifications. Based on OPD reviews, 78 (up 16 percent from 1998) drugs and biological products received designation as orphan products during the year. FDA estimates that past levels of sponsor orphan designation applications may soon be doubled. 
• Nineteen designated orphan drugs were approved for marketing:

Alitretinoin: Topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma.

Amifostine: Reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer.

Antihemophilic factor/von Willebrand factor complex(human), dried, pasteurized: Treatment and prevention of bleeding in hemophilia A(classical hemophilia) in adult patients; and treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate in adult and pediatric patients.

Atovaquone: Prevention of Pneumocystis carinii pneumonia (PCP) in high-risk, HIV-infected patients defined by a history of one or more episodes of PCP and/or a peripheral CD4+ (T4 helper/inducer) lymphocyte count less than or equal to 200/mm3.

Bexarotene: Treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.

Busulfan: As preparative therapy in the treatment of malignancies with bone marrow transplantation.

Caffeine: Treatment of apnea of prematurity.

Coagulation factor VIIa (recombinant): Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX.

Cytarabine liposomal: Treatment of neoplastic meningitis.

Denileukin diftitox: Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor.

Doxorubicin liposome: Treatment of ovarian cancer.

Epirubicin: Treatment of breast cancer.

Etanercept: Reduction in signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs.

Exemestane: Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy.

Levocarnitine: Treatment of manifestations of carnitine deficiency in patients with end stage renal disease who require dialysis.

Lidocaine patch 5 percent: For relief of allodynia (painful hypersensitivity), and chronic pain in post-herpetic neuralgia.

Nitric oxide: Treatment of persistent pulmonary hypertension in the newborn.

Somatropin(rDNA origin): Long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.

Temozolomide: Treatment of recurrent malignant glioma.

Human Drugs

Program Activity Data

1 ANDA actions include total of approvals, not approvables, tentative approvals, and faxed deficiencies. 

2 Chemistry, Manufacturing, & Controls and Labeling Supplements. Also includes global supplements. 

3 Includes postmarket samples analyzed in St. Louis, MO and Laurel, MD only. # FDA intends to solicit state contracts via the Federal Register. No states have entered into firm commitments, but have expressed interest.

Edited 3/1/2000