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news.Mylan Inc has announced that its subsidiary, Mylan Pharmaceuticals Inc has received tentative approval from the FDA for its abbreviated new drug application for venlafaxine hydrochloride extended-release capsules, 37.5mg, 75mg and 150mg.
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Venlafaxine HCl extended-release capsules, indicated for the treatment of major depressive disorder and generalized anxiety disorder, are the generic version of Wyeth Pharmaceutical’s Effexor XR capsules.
Currently, Mylan has 112 abbreviated new drug applications (ANDA) pending FDA approval, 23 of which are potential first-to-file opportunities.