Approval Date: October 22, 1987
Freedom of Information Summary
NADA 138-900
I. GENERAL INFORMATION:
NADA 138-900 Sponsor: Richlyn Laboratories, Inc.
Philadelphia, PA 19124Generic Name: dichlorophene/toluene capsules Trade Name: Dichlorophene/Toluene Capsules (Wormer for Dogs and Cats) Marketing Status: Over the Counter (OTC) II. INDICATIONS FOR USE
For removal of ascarids (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum and Uncinaria stenocephala) and as an aid in removal of tapeworms (Taenia pisiformis, Dipylidium caninum, and Echinococcus granulosus) from dogs and cats.
III. DOSAGE
A. DOSAGE FORM Capsule B. ROUTE OF ADMINISTRATION Oral C. RECOMMENDED DOSAGES: The drug is administered orally at a dose of 100 mg of dichlorophene and 120 mg of toluene per pound of body weight for dogs and cats. Solid foods and milk should be withheld for at least 12 hours prior to administration of the drug and for 4 hours afterwards. IV. EFFECTIVENESS
This application is filed as a generic equivalent to Vermiplex Capsules. Vermiplex was found to be effective by NAS/NRC review (NADA 6-691, Federal Register, February 1, 1969). Additionally, a regulation for this preparation Dichlorophene/Toluene was published as paragraph 520.580 for reference claims.
Jones, in Veterinary Pharmacology and Therapeutics, 2nd Ed., cites in vitro studies which support the safety and effectiveness of dichlorophene and toluene worming products: Blair, H.E., "Vermiplex, a new anthelmintic for dogs", North American Veterinarian, 30:306, 1949; and Buren, G.R. and Blair, H.E., "Vermiplex and anthelmintic for cats", North American Veterinarian,31:329, 1950. These studies demonstrate that dichlorophene and toluene are effective in removing certain ascarids and hookworms, and as an aid in removing certain tapeworms from dogs and cats.
V. ANIMAL SAFETY
Adequate data to establish the safety of this drug in dogs and cats are contained in the application by R.P. Scherer Corporation Master File, MF 3464. No bioequivalency data are required because this product is produced by R.P. Scherer for all sponsors.
VI. HUMAN SAFETY
A. Human Food Safety: Not applicable, for use in dogs and cats only.
B. Human Safety relative to possession, handling, and administration: Labeling contains adequate caution statement. The product is packaged in child resistant closure (screwcaps).
VII. AGENCY CONCLUSIONS
Data submitted satisfy the requirements of Section 512 of the Act and 514.111 of the implementing regulations. The Center for Veterinary Medicine concludes that this product is safe and effective as labeled for the above stated indications.
VIII. LABELING (Attached)
1. Container labels for 1, 2.5, 5, 10, 25, 40 pound size dogs and cats
Copies of these labels may be obtained by writing:
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.