Approval Date: February 14, 1989
I. GENERAL INFORMATION:
Elite Chemical Corp., Inc.
PO Box 1947
Norcross, Georgia 30091
dichlorophene-toluene worm capsules
Elite Dog & Cat Wormer, Elite Dog Wormer, Elite Cat Wormer
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.
ROUTE OF ADMINISTRATION
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 four hours afterwards.
IV. ANIMAL EFFICACY (EFFECTIVENESS):
This application is filed as a generic equivalent to Vermiplex Capsules. Vermiplex was found effective by NAS/NRC review (NADA 6-691, Federal Register , February 1, 1969). Additionally, a regulation for this preparation Toluene-Dichlorophene was published as paragraph 520.580 for reference claims.
Jones, in Veterinary Pharmacology and Therapeutics , 2nd Ed., cites two in vivo 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 Burch, G.R. and Blair, H.E., "Vermiplex, an anthelmintic for cats", North American Veterinarian, 31:329, 1950. These studies demonstrate that dichlorophene and toluene were effective in removing ascarids, hookworms, and 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 and data reviewed by NAS/NRC (Federal Register , February 1, 1969). No bioequivalency data was provided because this product is produced by R.P. Scherer for all sponsors.
VI. HUMAN SAFETY:
A. Data on human safety, pertaining to consumption of drug residues in food, were not required for approval of this NADA. The drug is labeled as an over-the-counter drug for use only in dogs and cats, which are non-food animals.
B. Human safety relative to possession, handling and administration:
Labeling contains adequate caution statement.
Labeling states: CAUTION HUMANS: If accidentally swallowed, do not induce vomiting. Call a physician immediately.
C. The product is packaged in child resistant containers.
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.
The drug is labeled for over the counter (OTC) use because it is a generic anthelmintic preparation with a long OTC marketing history of safe and effective use for the above indications.
- Elite Cat Wormer package labels for 1, 2.5, 5, and 10 lbs. of body weight
- Elite Dog Wormer package labels for 1, 2.5, 5, 10, 25, and 40 lbs. of body weight
- Elite Dog & Cat Wormer package labels for 1, 2.5, 5, and 10 lbs. of body weight
Copies of these labels may be obtained by writing to the:
Freedom of Information Office
Center for Veterinary Medicine, FDA
7500 Standish Place
Rockville, MD 20855