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Monday, April 19, 2010

Sun Pharma : USFDA tentative approval for generic Namenda® tablets

April 10, 2010: Sun Pharmaceutical Industries Ltd. 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... [PDF] Sun Pharmaceutical Industries' Press Release -