Mylan has 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, with a presence in more than 90 countries, ranks among the leading diversified generic and specialty pharmaceutical companies in the world. It 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.