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Drug Development

Generic drug developer receives U.S. FDA approval of sedative-reversing drug

Published in Medical Letter on the CDC and FDA, November 14th, 2004

Teva Pharmaceutical Industries Ltd. announced that the U.S. Food and Drug Administration has granted final approval for the company's abbreviated new drug application (ANDA) for Flumazenil Injection, 0.1 mg/mL. Commercial marketing of this product will begin immediately.

Flumazenil Injection is the AP-rated generic equivalent for HLR Technology's Romazicon Injection, a product used to reverse the sedative effects of benzodiazepines.

The brand product has annual sales of approximately $48 million.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 25 pharmaceutical companies and among the largest generic...

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