Mylan Receives Tentative FDA Approval for Generic Version of Singulair(R)

Fri, 05/29/2009 - 4:41am
Mylan Inc. has received tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) forMontelukast Sodium Tablets, 10 mg (base). Montelukast Sodium Tablets are the generic version of Merck and Co.'sSingulair(R), which had total U.S. sales of approximately $2.6 billion for the12 months ending March 31 for the same strength, according to IMS Health. Thisproduct is indicated for asthma and allergy treatment. Currently, Mylan has 117 ANDAs pending FDA approval representing $82.1billion in annual brand sales, according to IMS Health. Thirty-five of thesepending ANDAs are potential first-to-file opportunities, which represent $16.7billion in annual brand sales, according to IMS Health.

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