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The approval covers Venlafaxine Hydrochloride Extended-release Capsules in 37.5 mg, 75 mg and 150 mg forms. Venlafaxine HCl ER Capsules are indicated for the treatment of major depressive disorder and generalized anxiety disorder. Effexor had annual U.S. sales of around $3 billion for the twelve months ending September 30, according to IMS Health.
Currently, Mylan has 112 ANDAs pending FDA approval.
Pittsburgh-based Mylan is a generic and specialty pharmaceutical firm that provides products to customers in more than 140 countries and territories.
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