Mylan anounces FDA approval of Zolpidem Tartrate tablets

Published on April 24, 2007 at 7:18 AM · No Comments

Mylan Laboratories has announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Zolpidem Tartrate Tablets, 5 mg and 10 mg.

This product is being shipped immediately.

Zolpidem Tartrate Tablets are the generic version of Sanofi-Aventis' Ambien(R) Tablets. Ambien Tablets had U.S. sales of approximately $2.2 billion for the same strengths for the 12-month period ending Dec. 31, 2006, according to IMS Health.

http://www.mylan.com/

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Posted in: Pharmaceutical News

Tags: Ambien, Generic Drug, New Drug Application (NDA)

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