Mylan Inc.'s (MYL: Quote) subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration or FDA for its Abbreviated New Drug Application or ANDA for Montelukast Sodium Tablets, 10 mg, the generic version of Merck's Singulair Tablets. In addition, Mylan received final FDA approval for its ANDA for Montelukast Sodium Chewable Tablets, 4 mg and 5 mg, the generic version of Merck's Singulair Chewable Tablets.
The company said these products are indicated for the prophylaxis and chronic treatment of asthma in patients two years of age and older, for prevention of exercise-induced bronchoconstriction in patients 15 years of age and older, and for the relief of symptoms of seasonal and perennial allergic rhinitis in patients two years of age and older.
According to IMS Health, Montelukast Sodium Tablets, 10 mg, had U.S. sales of nearly $3.7 billion for the year ending June 30, 2012, and Montelukast Sodium Chewable Tablets, 4 mg and 5 mg, had U.S. sales of some $1.2 billion for year ending June 30, 2012. Mylan has begun shipping both of these products. Currently, Mylan has 166 ANDAs pending FDA approval representing $78.4 billion in annual sales, according to IMS Health.
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by RTT Staff Writer
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