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Wockhardt has received final approval from the US health regulator to sell its generic Venlafaxine Hydrochloride capsules used for treating depression in the American market.
The final approval by the United States Food and Drug Administration (USFDA) is for Venlafaxine Hydrochloride extended release capsules in strengths of 37.5 mg, 75 mg and 150 mg, the drug firm said in a filing to the Bombay Stock Exchange (BSE).
“Our product selection strategies have revolved around maximising our strengths in this area of pharmaceutical technology and Venlafaxine XR bears testimony to the same,” the Wockhardt Chairman, Mr Habil Khorakiwala, said.
Venlafaxine Hydrochloride extended release capsules are marketed by Pfizer under the brand name 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 June 1, 2011, it said.
The Mumbai-based firm would be manufacturing the product at its USFDA certified formulation plant at Chikalthana in Maharashtra.
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