APP Pharmaceuticals Receives FDA Approval for Polymyxin B Sulfate for Injection, USP

SCHAUMBURG, Ill.--(BUSINESS WIRE)--APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Polymyxin B Sulfate for Injection, USP, 500,000 units/vial, the equivalent of Bedford Laboratories Polymyxin B Sulfate. APP expects to commence marketing the product in the first quarter of 2008. APP’s polymyxin B is AP-rated, preservative and latex-free, and bar-coded at the individual unit-of-use. According to 2006 IMS data, sales of Polymyxin B Sulfate for Injection exceeded $13 million.

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