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APP Pharma wins approval for colistimethate for injection

APP Pharmaceuticals has received approval from the FDA of its abbreviated new drug application for colistimethate for injection, USP, 150mg.

Colistimethate for Injection, USP, 150mg is generic equivalent of JHP Pharmaceuticals’s Coly-Mycin M parenteral. APP has immediately commenced marketing and shipping the product. APP’s colistimethate is AP-rated, bar-coded and latex-free.

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.