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Amiodarone Hydrochloride Approved

SCHAUMBURG, Ill., Oct. 27 /PRNewswire-FirstCall/ -- American Pharmaceutical Partners, Inc. (NASDAQ:APPX) today announced it has received approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of amiodarone hydrochloride injection in 50mg strength, 18mL multi-dose vials. The company expects to commence marketing this product shortly. The approval brings to 15 the number of FDA product approvals APP has received since the beginning of 2004.

Amiodarone hydrochloride is indicated for the initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy, and is the generic equivalent of Wyeth Pharmaceuticals' Cordarone I.V.(R).

With this approval, APP is the only company currently with a full range of amiodarone products, having previously received approvals for this product in the 3mL and 9mL dosages, both in 50mg/mL strength. Sales of amiodarone 18mL were approximately $6 million in 2003, according to IMS.

Source: American Pharmaceutical Partners, Inc.

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