Aurobindo Pharma said on Monday that it has received final approval from the US health regulator to sell in American market its generic Venlafaxine Hydrochloride capsules, used for treating depression.
The final approval by the United States food and Drug Administration (USFDA) is for abbreviated new drug application (ANDA) for Venlafaxine Hydrochloride extended release capsules in the strengths of 37.5 mg, 75 mg and 150 mg, Aurobindo Pharma said in a statement.
Venlafaxine Hydrochloride extended release capsules are generic equivalent to largely circulated Wyeth Pharmaceuticals Inc’s Effexor XR capsules in the same strengths.
The product has a global market size of about $ 2.4 billion for the twelve months ending September 2010 according to IMS study group, and will be launched in the American market after June 1, 2011, the company added.
Venlafaxine Hydrochloride extended release capsules are used for treating major depressive disorder (MDD) and falls under central nervous system (CNS) category.