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American Pharmaceutical Partners, Inc.



American Pharmaceutical Partners receives U.S. FDA approval for Mitoxantrone



May 8th, 2006

American Pharmaceutical Partners, Inc., (APPX, APP) has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Mitoxantrone Injection, USP (Concentrate), the generic equivalent of Serono Labs' Novantrone.

According to IMS, sales in 2005 of mitoxantrone in the United States exceeded $76 million. APP expects to commence marketing mitoxantrone immediately. APP will sell mitoxantrone in AP-rated bar coded, latex-free vials with TALL man lettering.

Mitoxantrone Injection, USP in combination with corticosteroids is indicated as initial chemotherapy for the treatment of patients with pain...


Source: Biotech Week (2006-05-08)

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