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Flumazenil Injection Cleared by FDA

SCHAUMBURG, Ill., Oct. 13 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. (APP) (NASDAQ:APPX) , today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Flumazenil Injection, the generic equivalent of Roche Laboratories' Romazicon(R) 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 anesthesia 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.

Romazicon(R) Injection is a registered trademark of Roche Laboratories.

Source: American Pharmaceutical Partners, Inc.

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