Aurobindo Pharma Ltd, the Hyderabad-based drug company, received tentative approval from the US Food and Drug Administration (FDA) to manufacture and market venlafaxine hydrochloride extended-release capsules 37.5mg, 75mg and 150mg, said, a company release.
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 according to IMS.
The tentatively approved abbreviated new drug application (ANDA) for venlafaxine hydrochloride extended-release capsules 37.5mg, 75mg and 150mg was filed with Paragraph IV certification and is currently under litigation in the United States District Court for the District of New Jersey with Wyeth LLC. The product will be launched after the litigation settlement, the company said.
Aurobindo now has a total of 132 ANDA approvals, including 99 final approvals and 33 tentative approvals, from the US FDA