Mylan Announces Final FDA Approval for Zaleplo...( PITTSBURGH June 9 /- Mylan Inc. (...),Health
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Mylan Announces Final FDA Approval for Zaleplon Capsules
Date:6/9/2008
PITTSBURGH, June 9 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that its subsidiary, Genpharm ULC, has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Zaleplon Capsules, 5 mg and 10 mg.
Zaleplon Capsules are the generic version of King Pharmaceuticals' Sonata(R) Capsules, which had U.S. sales of approximately $88 million for the 12 months ending March 31, 2008, according to IMS Health.
This product is shipping immediately and will be sold under the Mylan Pharmaceuticals brand.
Mylan Inc., with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. The company maintains one of the industry's broadest -- and highest quality -- product portfolios, supported by a robust product pipeline; owns a controlling interest in the world's second largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies.
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