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Generic Drugs

Pharma company announces final U.S. FDA approval for alprazolam extended-release tablets

Published in Medical Letter on the CDC and FDA, March 5th, 2006

Mylan Laboratories Inc. (MYL) announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for alprazolam extended-release tablets, 0.5 mg, 1 mg, 2 mg and 3 mg.

Alprazolam extended-release tablets are the AB-rated generic equivalent of Pharmacia's and Upjohn's Xanax XR Tablets, an antianxiety drug which had U.S. sales of approximately $100 million for the 12-month period ending June 30, 2005, according to IMS Health.

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Mylan Laboratories Inc. is a pharmaceutical company with three...

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