Mylan Labs announces final FDA approval and immediate shipment of zolpidem tartrate tablets

Mon Apr 23, 2007 12:47pm EDT

Co announces it received final approval from the FDA for its Abbreviated New Drug Application 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' (SNY) Ambien Tablets. Ambien Tablets had U.S. sales of approx $2.2 bln for the same strengths for the 12-month period ending Dec. 31, 2006, according to IMS Health.

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