BMY » Topics » FOURTH NEW DRUG APPROVED

This excerpt taken from the BMY 8-K filed Apr 28, 2005.

FOURTH NEW DRUG APPROVED

 

Bristol-Myers Squibb obtained its fourth new drug approval in just two and a half years when, in March 2005, the Food and Drug Administration approved BARACLUDE® (entecavir) for treatment of chronic hepatitis B infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.

 

“We were pleased by the FDA’s approval of BARACLUDE® following the unanimous recommendation of the Antiviral Drugs Advisory Committee and we are in regulatory reviews with FDA on muraglitazar and abatacept,” said Elliott Sigal, M.D., Ph.D., chief scientific officer and president of the Bristol Myers Squibb Pharmaceutical Research Institute. “First quarter progress in our pipeline was also demonstrated by FDA approval of a new ABILIFY® indication for maintaining efficacy in patients with Bipolar I Disorder, as well as the results of the ‘CLARITY’ and ‘COMMIT’ trials for PLAVIX®.”

 

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