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APP Pharmaceuticals, Inc. 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
SCHAUMBURG, Ill., USA | 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.
About APP Pharmaceuticals
APP is a specialty drug company that develops, manufactures and markets injectable pharmaceutical products, focusing on oncology, anti-infective, anesthetic/analgesic and critical care markets. The company is one of the largest producers of injectables, with more than 100 products in more than 400 dosage formulations. APP, headquartered in Schaumburg, Illinois, has offices in Canada and manufacturing operations in Illinois, New York and Puerto Rico and is traded on the Nasdaq Global Market under the symbol APPX. For more information about APP and the products it provides, please visit www.APPpharma.com.
SOURCE: APP Pharmaceuticals, Inc.
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