PITTSBURGH, April 19 /PRNewswire-FirstCall/ -- Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration (FDA) under the President’s Emergency Plan for AIDS Relief (PEPFAR) for its Abbreviated New Drug Application (ANDA) for Didanosine Delayed-release Capsules, 125 mg, 200 mg, 250 mg and 400 mg, the generic version of Bristol Myers Squibb’s HIV treatment Videx((R) )EC. This product, which the company expects to begin marketing in the U.S. during the current quarter, will be sold under the Mylan Pharmaceuticals brand. The product will also be sold outside the U.S. in a number of developing countries.
Currently, Mylan has 140 ANDAs pending FDA approval representing $98.3 billion in annual brand sales, according to IMS Health. Thirty-eight of these pending ANDAs are potential first-to-file opportunities, representing $19.8 billion in annual brand sales, for the 12 months ending Dec. 31, 2009, according to IMS Health.
Mylan Inc. ranks among the leading generic and specialty pharmaceutical companies in the world and provides products to customers in more than 140 countries and territories. The company maintains one of the industry’s broadest and highest quality product portfolios supported by a robust product pipeline; operates one of the world’s largest active pharmaceutical ingredient manufacturers; and runs a specialty business focused on respiratory, allergy and psychiatric therapies. For more information, please visit 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/
