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U.S. Department of Health and Human Services

Animal & Veterinary

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UPDATE ON FY 98 APPROVALS

FDA Veterinarian Newsletter March/April 1999 Volume XIV, No II

CVM's Office of New Animal Drug Evaluation acted on 6,513 submissions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), investigational new animal drug files (INADs), and generic investigational new animal drug (JINADs) files in Fiscal Year (FY) 1998. Approximately 85 percent of these decisions were made within the statutory limit of 180 days for NADAs and ANADAs and the internally established time frame for INADs and JINADs. Of the 6,513 applications, 102 were for original applications (and reactivated originals) and 835 were for supplements to previously approved applications. In addition, 428 phased data submissions were completed by the Center during FY 1998. The on-time rate for these applications and substantial submissions was 75 percent.

Of the actions taken in FY 1998, FDA published 101 documents reflecting NADA and ANADA approvals in the Federal Register. These approvals included some very significant new product approvals, i.e., 10 new chemical entities, 10 products for use in new animal species, and 4 products available in new dosage forms. In addition, other approvals included 28 original generic approvals, 4 drug effectiveness study implementation (DESI) finalizations, 5 new product indications, and 3 additional production classes approved through supplements to existing approved drugs.

The new chemical entities approved in FY 98 included the ones listed in the table below.

A complete list of all FY 98 animal drug approvals is available from the FDA Veterinarian.

DrugSpeciesSponsorNADA Number
ClenbuterolHorsesBoehringer Ingelheim140-973
Desoxycorticosterone PivalateDogsNovartis141-029
Deslorelin AcetateHorses (Mares)Peptech 141-044141-044
HemaglobinDogsBiopure 141-067141-067
Colistimethate SodiumChickensAlpharma 141-069141-069
Doxycycline HyclateDogsHeska141-082
Difloxacin HydrochlorideDogsFort Dodge141-096
Competitive ExclusionChickensMilk Specialties141-101
Culture   
B-Aminopropionitrile FumarateHorsesAlaco141-107
EtodolacDogsFort Dodge141-108