Mylan Inc, announced that its subsidiary, Genpharm ULC, has received final approval from the US 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 capsules, which had US 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.