Sun Pharmaceutical Industries' generic Namenda ANDA: USFDA grants tentative approval

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Apr 12 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 Forest Laboratories, Inc.'s Namenda 5 mg and 10 mg tablets.

These generic Memantine tablets are equivalent to Forest Laboratories, Inc's Namenda® tablets and includes two strengths: 5 mg and 10 mg. These strengths of Memantine have a combined annual sale of approximately $1.2 billion in the US.

Memantine tablets are indicated for the treatment of moderate to severe Alzheimer's Disease.

Source:

Sun Pharmaceutical Industries Ltd.

Posted in: Medical Condition News | Pharmaceutical News

Tags: Alzheimer's Disease, Cardiology, Gastroenterology, Neurology, New Drug Application, Pharmaceuticals, Psychiatry

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