The product is used to reverse the sedative effects of benzodiazepines.
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA) announced today that the US Food and Drug Administration had granted final approval for its ANDA (abbreviated new drug application) for Flumazenil Injection,0.1 mg/mL. Teva said commercial marketing of this product would 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.
According to Teva, the brand product has annual sales of approximately $48 million.
Published by Globes [online] - www.globes.co.il - on October 13, 2004