SCHAUMBURG, Ill.--(BUSINESS WIRE)--Jan 17, 2008 - 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.
Polymyxin B Sulfate for Injection is indicated for the treatment of acute infections caused by susceptible strains of pseudomonous aeruginosa. It may be used topically or subconjunctively in the treatment of infections of the eye caused by susceptible strains of the same organism. It may also be indicated in the case of serious infections caused by specific indicated organisms.
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