- No lawsuit filed within statutory 45-day window -
PITTSBURGH, Oct. 29 /PRNewswire-FirstCall/ -- Mylan Inc. (NYSE: MYL) today announced that Matrix Laboratories Limited, its India-based subsidiary in which it holds a 71.5% controlling interest, has challenged Pfizer Inc.'s patents for its Vfend(R) Tablets, 50 mg and 200 mg, with the filing of its Abbreviated New Drug Application (ANDA). Pfizer did not file a lawsuit against Matrix within the 45-day time period provided by the Hatch-Waxman Act to initiate an automatic stay of regulatory approval. Therefore, Matrix's ANDA will be eligible for final approval as soon as regulatory review is complete.
Matrix submitted its ANDA for Voriconazole Tablets, the generic version of Vfend, with the U.S. Food and Drug Administration (FDA) on April 14, 2008, and believes it is the first company to submit a substantially complete ANDA containing a Paragraph IV certification. Under the provisions of the Hatch-Waxman Act, it is anticipated that Matrix will be entitled to 180 days of marketing exclusivity for Voriconazole upon FDA approval.
Vfend Tablets, a triazole antifungal agent, had annual U.S. sales of approximately $157 million for the 12 months ending June 30, 2008, for the noted strengths, according to IMS Health.
Currently, Mylan has 112 ANDAs pending FDA approval, 23 of which are potential first-to-file opportunities.
Mylan Inc., which provides products to customers in more than 140 countries and territories, 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. For more information, please visit http://www.mylan.com.
|SOURCE Mylan Inc.|
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