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U.S. Department of Health and Human Services

Animal & Veterinary

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UPDATE ON DRUG APPROVALS IN FY 97

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

The Center for Veterinary Medicine announced 102 new animal drug-related approvals for Fiscal Year 1997 (FY 97), up from 80 in FY 96.

Thirty-seven (37) of these approvals were for generic drugs. Seven (7) approvals were for new species, and one was for new minor species, in this case sheep. Nine (9) approvals were for new production class, 6 were for new chemical entities, 2 new formulations, 3 DESI-finalizations, 2 new tolerances, 1 new combination, 6 new indications, and 2 new routes. CVM classifies 76 of the 102 approvals as "significant" new animal drug approvals. The Center defines as "significant" those approvals involving new chemical entities (first time for use in animals), new species, new indications, new combinations, new tolerances, generic drugs, minor species, new production classes, and DESI-finalizations. For FY 96, CVM had 66 "significant" approvals out of 80 new animal drug approvals.

The new chemical entities approved in FY 97 included the ones listed in the table below.

A complete list of all FY 97 animal drug approvals is available from the FDA Veterinarian.

Drug
(Trade Name)
SpeciesSponsorNADA Number
CarprofenDogsPfizer141-053
PropofolDogsMallinckrodt141-070
FomepizoleDogsOrphan Medical141-075
EprinomectinCattleMerck141-079
Selegiline HydrochlorideDogsDeprenyl Animal Health141-080
OrbifloxacinDogsSchering Plough141-081