American Pharmaceutical Partners Inc has received approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Flumazenil Injection, the generic equivalent of Roche Laboratories' Romazicon Injection.
APP expects to immediately commence marketing flumazenil, which had sales of $39.7 million in 2003, according to IMS. Flumazenil brings to 12 the number of product approvals APP has received year to date.
Flumazenil Injection is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anaesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.
American Pharmaceutical Partners Inc is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on the oncology, anti-infective and critical care markets.
APP has acquired the exclusive North American rights to manufacture and market Abraxane, a proprietary nanoparticle injectable oncology product that has completed phase III clinical trials for metastatic breast cancer.