Mylan Inc. Receives Final FDA Approvals for Generic Versions of Anti-Rejection Medication CellCept(R)
PITTSBURGH, May 7 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approvals from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDAs) for Mycophenolate Mofetil Tablets, 500 mg, and Mycophenolate Mofetil Capsules, 250 mg.
Mycophenolate Mofetil is the generic name for Roche's CellCept(R), which is indicated for the prevention of organ rejection in patients receiving kidney, heart or liver transplants. CellCept Tablets, 500 mg, and CellCept Capsules, 250 mg, had annual U.S. sales of approximately $680 million and $367 million, respectively, for the 12 months ending March 31, 2009, according to IMS Health. Mylan has commenced shipping both products.
Mylan Inc., which provides products to customers in more than 140 countries and territories, ranks among the leading diversified generics 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 third largest active pharmaceutical ingredient manufacturer; and operates a specialty business focused on respiratory and allergy therapies. For more information, please visit http://www.mylan.com.
CONTACT: Media, Michael Laffin, +1-724-514-1968, or Investors Dan
Crookshank, +1-724-514-1813, both of Mylan Inc.
Web site: http://www.mylan.com/