Mylan Inc. 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.
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