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news.Mylan has announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the FDA for its abbreviated new drug application for Venlafaxine hydrochloride tablets 25mg, 37.5mg, 50mg, 75mg and 100mg.
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Venlafaxine hydrochloride tablets, indicated for the treatment of major depressive disorder, are the generic version of Wyeth’s Effexor tablets.
This product is shipping immediately. Currently, Mylan has 92 abbreviated new drug applications pending FDA approval, 20 of which are potential first-to-file opportunities.