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The Associated Press June 21, 2010, 8:36AM ET

FDA grants approval for APP Pharmaceuticals drug

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.


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