PITTSBURGH, June 9 /PRNewswire-FirstCall/ -- 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.
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.
CONTACT: Media, Michael Laffin, or Investors, Kris King, both of Mylan
Inc., +1-724-514-1813
Web site: http://www.mylan.com/