Mylan Inc. (MYL), on Tuesday said its privately held Indian subsidiary, Matrix Laboratories Ltd. has received final approval from the US Food and Drug Administration for its Abbreviated New Drug Application for Lansoprazole Delayed-release Capsules, indicated in the treatment of Acid Reflux Disease.
The Canonsburg, Pennsylvania-based specialty pharma's Lansoprazole DR Capsules, 15 mg and 30 mg, are the generic version of Tap Pharmaceuticals' proton pump inhibitor Prevacid DR Capsules.
Lansoprazole Capsules had total U.S. sales of nearly $3 billion for the 12 months ending June 30, 2009 for the same strengths, according to IMS Health.
Mylan currently has 125 ANDAs pending FDA approval, which translates into $84.1 billion in annual brand sales according to stats provided by IMS Health. Thirty-seven of these pending ANDAs are potential first-to-file opportunities, representing $19.2 billion in annual brand sales.
MYL is trading at $17.57, down $0.34 or 1.90%, on a volume of 6.42 million shares on the Nasdaq.
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