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U.S. Department of Health and Human Services

Animal & Veterinary

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SUPPLEMENTAL NEW ANIMAL DRUG APPROVALS

FDA Veterinarian Newsletter January/February 1998 Volume XIII, No I

CompanyGeneric and (Brand) NamesIndicationsRoutes/Remarks
Mallinckrodt Veterinary, Inc. (NADAs 34-266, 34-697, 139-858) and PM Resources, Inc. (NADA 43-215)Famphur -- Famix Famphur Type A article (for Type C Cattle Feed) (NADA 34-266), Warbex Famphur Cattle Pour-On/Bo-Anna Famphur Cattle Insecticide (NADA 34-697), Tramisol-X-Tra (Famphur/Levamisole) Cattle Anthelmintic and Ecoparasite Paste (NADA 139-858), and Purina Grub-Kill (Famphur) (NADA 43-215)CattleMEDICATED FEED/TOPICAL -- TOLERANCES. The animal drug regulations are amended to specify the tolerances for residues of famphur in cattle products. The residue tolerances were originally issued in FDA¹s regulations under tolerances and exemptions from tolerances for pesticide chemicals in or on raw agricultural commodities, and subsequently moved to the EPA regulations for residues of pesticides. Subsequent FDA NADA approvals with the same tolerances, instead of stating the tolerances, cross- reference EPA¹s regulations. This action is being taken because EPA has removed the tolerance from its regulations. Federal Register 10/23/97.
Pfizer, Inc. (NADA 141-061)Doramectin (Dectomax®)SwineINJECTABLE: Provides for intramuscular use in swine for treatment and control of certain infections of gastrointestinal roundworms, lungworms, kidney worms, sucking lice, and mange mites. In addition, the CFR (21 CFR 556.225) is amended to provide for a tolerance for residues of doramectin in swine tissues. A tolerance of 0.1 ppm is established for parent doramectin in liver of cattle and 0.16 ppm in liver of swine. Federal Register 11/21/97.
Hoffmann-LaRoche, Inc. (NADA 48-761)ChlortetracyclineBeef and non-lactating dairy cattle. For control of anaplasmosis and other uses.MEDICATED FEED: Provides for changing the withdrawal time to zero following certain uses of chlortetracycline in Type C cattle feeds (including free-choice feeds). Federal Register 11/19/97.
Schering Plough Animal Health Corp. (NADA 141-081)OrbifloxacinCatsORAL: Provides for prescription use in cats for management of susceptible bacterial disease. Federal