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Mylan Pharma Venlafaxine HCl extended-release capsules win FDA approval

Mylan Pharmaceuticals, a subsidiary of Mylan, has received the US Food and Drug Administration (FDA) approval for its abbreviated new drug application (ANDA) for Venlafaxine Hydrochloride (HCl) extended-release (ER) capsules, 37.5mg (base), 75mg (base) and 150mg (base).

The capsules are the generic version of Wyeth’s Effexor XR capsules, which are used in the treatment of major depressive disorder and social anxiety disorder.

Mylan is launching the products under a license agreement with Wyeth, a part of Pfizer.

Currently, Mylan has 164 ANDAs pending FDA approval.