USFDA grants Sun Pharma tentative approval for generic Stalevo ANDA

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Oct 1 2010

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Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary a tentative approval for its Abbreviated New Drug Application (ANDA) to market a generic version of Orion's Stalevo^® tablets.

These generic Carbidopa, Levodopa and Entacapone tablets contain Carbidopa, Levodopa and Entacapone 25/100/200 mg, and 37.5/150/200 mg.

Generic Carbidopa, Levodopa and Entacapone tablets are indicated in the treatment of Parkinson's disease.

These strengths of Stalevo^® have annual sales of approximately $ 95 million in the US.

Source:

Sun Pharmaceutical Industries Ltd.

Posted in: Medical Condition News | Pharmaceutical News

Tags: Carbidopa, Cardiology, Gastroenterology, Levodopa, Neurology, New Drug Application, Parkinson's Disease, Pharmaceuticals, Psychiatry

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