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UPDATE ON DRUG APPROVALS IN FY 95
The Center for Veterinary Medicine announced 51 new animal drug-related approvals
for Fiscal Year 1995 (FY 95). Twenty-three of these approvals were for generic
drugs. In addition, 9 were for new species, 6 new sub-species (class), 4 were
for new chemical entities, 3 new strength, 2 DESI-finalization, 2 new tolerances,
and one each for a new combination and for a new indication. CVM classifies
49 of the 51 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 94, CVM had 36 "significant"
approvals out of 60 new animal drug approvals.
The new chemical entities approved in FY 95 included the ones listed in the
table below:
A complete list of all FY 95 animal drug approvals is available from the FDA
Veterinarian.
| Drug(Trade Name) |
Species |
Sponsor |
NADA Number |
| Lufenuron (Program
®) |
Dogs |
Ciba-Geigy |
141-035 |
| Melarsomine (Immiticide
®) |
Dogs |
Rhone Merieux |
141-042 |
| Cyclosporine (Optimmune
®) |
Dogs |
Schering-Plough |
141-052 |
| Sarafloxacin Hydrochloride
(SaraFlox ® WSP) |
Chickens (broilers) |
Abbott Labs |
141-017 |
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Source: May/June 1996 FDA Veterinarian Newsletter
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