Aurobindo Pharma Limited has received tentative approval from the US Food & Drug Administration to make and sell Venlafaxine Hydrochloride Extended-release
These 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 US$ 2.4 billion (in 2010) according to IMS.
The tentatively approved ANDA is currently under litigation in the United States District Court [Wyeth LLC v. Aurobindo Pharma Limited]. The product will be launched after the litigation settlement.
Headquartered in India’s Hyderabad, Aurobindo Pharma Limited (www.aurobindo.com) makes generic pharmaceuticals and active pharmaceutical ingredients.