Teva Pharmaceutical granted FDA approval for Flumazenil injection

Oct 13 2004

Teva Pharmaceutical Industries Ltd. has announced that the U.S. Food and Drug Administration has granted final approval for the Company’s 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 pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva’s sales are in North America and Europe.