New Delhi: Drug firm Wockhardt on Tuesday said 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 Venlafaxine Hydrochloride extended release capsules in the strengths of 37.5 mg, 75 mg and 150 mg, Wockhardt said in a filing to the Bombay Stock Exchange (BSE).
“Our product selection strategies have revolved around maximizing our strengths in this area of pharmaceutical technology and Venlafaxine XR bears testimony to the same,” Wockhardt chairman Habil Khorakiwala said.
Venlafaxine Hydrochloride extended release capsules are marketed by Pfizer under the brand name of Effexor XR in the United States.
The product has a global market size of about $2.3 billion according to IMS Health. The company plans to launch the product in the American market on 1 June, 2011, it said.
The Mumbai-based firm would be manufacturing the product at its US FDA certified formulation plant at Chikalthana in Maharashtra.
Shares of Wockhardt were trading at Rs361 on the Bombay Stock Exchange (BSE) in the late afternoon trade, up 4.17% from its previous close.