Mylan Announces Approval Under PEPFAR for Generic Version of Videx(R) EC HIV Treatment
PITTSBURGH, April 19 Mylan Inc. (Nasdaq: MYL) 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(Ū )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.
Didanosine Delayed-release Capsules had U.S. sales of approximately $29 million for the 12 months ending Dec. 31, 2009, according to IMS Health.
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.
This press release includes statements that constitute "forward-looking statements," including with regard to the expected timing to market the product and first-to-file opportunities. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward- looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the use of legal, regulatory and legislative strategies by competitors or other third parties to delay or prevent product introductions; and the other risks detailed in the company's filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release.
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.
SOURCE Mylan Inc.
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