Aurobindo Pharma Ltd received final approval for venlafaxine hydrochloride extended-release capsules 37.5mg, 75mg and 150mg from the US Food and Drug Administration (US FDA).
Venlafaxine hydrochloride extended-release capsules 37.5mg, 75mg and 150mg are the generic equivalent of Wyeth Pharmaceuticals Inc’s Effexor XR capsules 37.5mg, 75mg and 150mg. Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD) and falls under the neurological (CNS) therapeutic category.
The product has a market size of approximately US$ 2.4 billion for the twelve months ending September 2010. Aurobindo will launch the products after June 1, 2011. The Hyderabad-based company now has a total of 134 ANDA approvals, including103 final approvals and 31 tentative approvals from the US FDA.