Mylan receives FDA approval for Azithromycin tablets

Jun 1 2007

Mylan Laboratories Inc. has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Azithromycin Tablets, 250 mg and 500 mg.

Azithromycin Tablets are the generic version of Pfizer's Zithromax(R) Tablets. Azithromycin Tablets had U.S. sales of approximately $886 million for the 12 months ending March 31, 2007, for the same strengths.

This product will be shipped immediately.

Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.