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Mylan Receives Final FDA Approval for First Generic Version of Doryx Tablets, 150 mg
Posted February 9, 2012
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FDA Denies Warner Chilcott's Citizen Petition
PITTSBURGH -- Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Delayed-release (DR) Tablets USP, 150 mg. This product is the generic version of Mayne Pharma's Doryx®(marketed by Warner Chilcott), which is a tetracycline-class antimicrobial.
Mylan CEO Heather Bresch commented: "We are gratified by FDA's approval of our generic Doryx 150 mg product. We have strongly believed from the very beginning that Warner Chilcott's citizen petition in reference to this product was baseless and are extremely pleased that FDA has now denied this petition."
Mylan has agreed that it will not launch its generic Doryx product until after a decision is issued in Warner Chilcott's patent infringement lawsuit against Mylan. This trial is underway in the U.S. District Court for the District of New Jersey (Newark) and a decision is currently expected in March.
Doxycycline Hyclate DR Tablets had U.S. sales of approximately $264.1 million for the 12 months endingDec. 31, 2011, according to IMS Health.
Currently, Mylan has 173 ANDAs pending FDA approval representing $98.3 billion in annual sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $26.6 billion in annual brand sales, for the 12 months ending June 30, 2011, 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 150 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 about Mylan, please visit www.mylan.com. For more information about generic drugs, please visit www.ChoosingGenerics.com.
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