Mylan receives final FDA approval for Montelukast Sodium Tablets ANDA

Aug 7 2012

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Montelukast Sodium Tablets, 10 mg, the generic version of Merck's Singulair® Tablets. Mylan also 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. 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.

Montelukast Sodium Tablets, 10 mg, had U.S. sales of approximately $3.7 billion for the 12 months ending June 30, 2012, and Montelukast Sodium Chewable Tablets, 4 mg and 5 mg, had U.S. sales of approximately $1.2 billion for the 12 months ending June 30, 2012, according to IMS Health. 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. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $25.1 billion in annual brand sales, for the 12 months ending Dec. 31, 2011, according to IMS Health.