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U.S. Department of Health and Human Services

Animal & Veterinary

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UPDATE ON FY 99 APPROVALS

FDA Veterinarian Newsletter March/April 2000 Volume XV, No II

CVM's Office of New Animal Drug Evaluation acted on 5,968 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 FY 99 compared to 6,513 in FY 98. Approximately 85 percent of these decisions were made within the statutory and internal limits of 180 days. Of the 5,968 applications, 75 were for original applications (and reactivated originals) and 873 were for supplements to previously approved applications. In addition, 385 phased data submissions were completed by the Center during FY 99. The on-time rate for these applications and substantial submissions was 75 percent.

Approvals included very significant new product approvals, i.e., 5 new chemical entities, 9 products for use in new animal species, 6 with new tolerances/withdrawal times, and 17 with new indications. In addition, other approvals included 7 original generic approvals, 5 with new formulations, and 2 with new strengths/concentrations.

The new chemical entities approved in FY 99 included are listed in the table below.

A complete list of all FY 99 animal drug approvals is available from the FDA Veterinarian. Additional information about FDA-approved veterinary drugs is included on the Center's Home Page in the Electronic Green Book.