The US Food and Drug Administration has granted final approval for Teva Pharmaceutical's ANDA for Flumazenil Injection, 0.1 mg/mL. Commercial marketing of this product will begin immediately, the company informed here.
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, develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90 per cent of Teva's sales are in North America and Europe.