April 21, 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 Colistimethate for Injection, USP, 150 mg, the generic equivalent of JHP Pharmaceuticals' Coly-Mycin(R) M Parenteral. APP has immediately commenced marketing and shipping the product. APP's colistimethate is AP-rated, bar-coded and latex-free. According to IMS data, U.S. sales of colistimethate in the United States were approximately $15.4 million in 2007.
Colistimethate is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by pseudomonas aeruginosa.
(Source: www.pharmalive.com)
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