Sun Pharma announces USFDA approval for generic Namenda® tablets

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an 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.

Sun was amongst the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification to the '703 patent. Sun's subsidiary is eligible for 180 days generic exclusivity.

These generic Memantine tablets are equivalent to Forest Laboratories, Inc's Namenda® tablets and include 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.

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