Aurobindo Signs The U.S. FDA For Venlafaxine Capsule

City-based Aurobindo Pharma Ltd has received final approval for venlafaxine hydrochloride extended-release capsules of 37.5 mg, 75 mg and 150 mg U.S. Food and Drug Administration (FDA).

venlafaxine HCl extended release capsules 37.5 mg, 75 mg and 150 mg are common to Wyeth Pharmaceuticals, Inc. Effexor XR 37.5 mg, 75 mg and 150 mg. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD) and is a neurological (CNS) therapeutic class, the press release the company said.

The product has a market size of $ 2.4 billion for the twelve months ending September 2010. Aurobindo will launch the products after June 1, 2011. The company now has a total of 134 ANDA approvals, including103 final approvals and 31 tentative approvals from the FDA.