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APP Pharmaceuticals received marketing approval for its generic anti-infective treatment, the company said Monday.
The Food and Drug Administration gave approval to market Aztreonam for Injection in two dosage strengths, 1 gram 20 milliliters and 2 grams 30 milliliters. APP plans to launch Aztreonam immediately.
It said Aztreonam is therapeutically equivalent to the Bristol-Myers Squibb Co. drug Azactam. The branded product had about $86 million in U.S. sales last year.
Aztreonam is intended to treat urinary tract, gynecologic and skin infections, and others.
APP Pharmaceuticals Inc. is a subsidiary of Fresenius Kabi Pharmaceuticals Holding Inc.