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Mylan Receives Tentative FDA Approval for Generic Version of Singulair
Mylan, 06/01/09
Mylan Inc. announced that it has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Montelukast Sodium Tablets, 10 mg. Montelukast Sodium Tablets are the generic version of Merck and Co.'s Singulair, which had total U.S. sales of approximately $2.6 billion for the 12 months ending March for the same strength, according to IMS Health. This product is indicated for asthma and allergy treatment.
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