Approval Date: September 12, 1991
Freedom of Information Summary
NADA 133-953
I. GENERAL INFORMATION:
NADA 133-953 Sponsor: Mobay Corporation
Animal Health Division
P. O. Box 390
Shawnee, KS 66201Generic Name: Febantel and Praziquantel Trade Name: Vercom Paste Anthelmintic Marketing Status: Prescription Effect of Supplement: This supplement provides for the addition of the following warning statement to the label: "Warning: Consider alternative therapy or use with caution in animals with pre-existing liver or kidney dysfunction." II. INDICATIONS FOR USE
Vercom Paste Anthelmintic is indicated for the removal of the following nematode parasites (these are unchanged by this supplement):
In Dogs and Puppies:
Hookworms (Ancylostoma caninum, Uncinaria stenocephala)
Ascarids (Toxocara canis, Toxocara leonina)
Whipworms (Trichuris vulpis)
Tapeworms (Dipylidium caninum and Taenia pisiformis)
In Cats and Kittens:
Hookworms (Ancylostoma tubaeforme)
Ascarids (Toxocara cati)
Tapeworms (Dipylidium caninum and Taenia taeniaeformis)III. DOSAGE
A. DOSAGE FORM Paste B. ROUTE OF ADMINISTRATION
Oral; directly into the mouth or, for mature animals, mixed with food and fed to the animal.
C. RECOMMENDED DOSAGES:
Dogs and Cats:
1 g/7.5 lb body weight (BW) given to mature dogs and cats (10 mg febantel and 1.0 mg praziquantel/kg BW) given daily for 3 consecutive days.
Puppies and Kittens younger than 6 mo. of age:
1 g/5 lb BW (15 mg febantel and 1.5 mg praziquantel/kg BW) given on a full stomach daily for 3 consecutive days.
IV. EFFECTIVENESS
Well-controlled critical anthelmintic studies (which involved the sacrificing of animals and examination to determine the number of parasites in the intestinal tract) were conducted to establish and confirm the minimum effective dose of Vercom paste. These studies are included in the original FOI Summary for Vercom Paste, NADA 133-953 (50 FR 19167). Additional data were collected and a supplement was approved extending the parasite spectrum for which the drug is approved, and this FOI summary is also available (53 FR 48533).
V. ANIMAL SAFETY
This supplement provides for the addition of the following warning statement to the label, "Warning: Consider alternative therapy or use with caution in animals with pre-existing liver or kidney dysfunction."
The addition of this warning is based on data gathered during the safety evaluation of febantel alone for Rintal Tabs, NADA 140-912. A summary of this data can be found in the F.O.I. for that product under the heading, General Safety Evaluation (General Safety Evaluation for the Use of Febantel Tablets in Cats). It was shown in this study, that, at elevated doses, toxicity may be increased in the animal already compromised by hepatic or renal disease.
VI. HUMAN SAFETY:
a. Human Food Safety
Data on human safety, pertaining to consumption of drug residues in food, were not required for approval of NADA. The drug (febantel and praziquantel) is labeled for use in dogs and cats only.
b. Safety Relative to Possession, Handling and Administration
Laboratory animal toxicity studies verify the lack of potential hazards to human handling of the formulation. The label states: Keep out of reach of children.
VII. AGENCY CONCLUSIONS
Under the Center's supplemental approval policy (55 FR 46045), published November 1, 1990, this is a Category II change because it provides solely for the addition of a user warning statement. The approval of this supplemental application has no adverse effect on the safety and effectiveness of this new animal drug. Accordingly, this approval did not require a reevaluation of the safety and effectiveness data in the parent application. Safety is enhanced by the addition of the following labeling statement:
"Warning: Consider alternative therapy or use with caution in animals with pre-existing liver or kidney dysfunction."
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F), this approval does not qualify for any term of marketing exclusivity because no new clinical or field investigations conducted by the sponsor were essential to the approval of this supplemental NADA.
The expertise of a trained professional is required for a definitive diagnosis, to monitor the results of treatment, and determine the occurrence of adverse effects; therefore, the drug is a prescription product.
VIII. LABELING (Attached)
1. Unit Label 4.8 g Syringe
2. 4.8 g Syringe Insert
3. 4.8 g Syringe Unit Carton
4. Multi-carton 4.8 g Front Panel
5. Multi-carton 4.8 g Back Panel
6. Multi-carton 4.8 g End Panel
7. Multi-carton 4.8 g Top Panel
8. 12 g Syringe Unit Label
9. 12 g Syringe Insert
10. Unit Carton 12 g Syringe
11. Top Panel Multi-carton 12 g Syringe
12. Front Panel Multi-carton 12 g Syringe
13. Back Panel Multi-carton 12 g Syringe
14. End Panel Multi-carton 12 g Syringe
15. Unit Label 36 g Syringe
16. Insert 36 g Syringe
17. Inside of Top Panel/Multi-carton 36 g Syringe
18. Top Panel Multi-carton 36 g syringe
19. Multi-carton 36-g Syringe
Copies of these labels may be obtained by writing to the:
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane
Rockville, MD 20857
Or requests may be sent via fax to: (301) 443-1726. If there are problems sending a fax, call (301) 443-2414.