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Sun Pharmaceutical Gets FDA Tentative Approval For Generic Namenda Tablets

Sun Pharmaceutical Industries has reported that FDA has granted its subsidiary a tentative approval for its abbreviated new drug application (ANDA) to market a generic version of Forest Laboratories’s Namenda tablets.

The generic Memantine tablets are equivalent to Forest Laboratories’ Namenda tablets and includes two strengths: 5 mg and 10 mg. Reportedly, both the strengths of Memantine have a combined annual sale of approximately $1.2bn in the US.

Namenda tablets are used for treating moderate to severe Alzheimer-type dementia. Namenda is a NMDA-receptor antagonist. It works by blocking excess activity of a substance in the brain called glutamate, which may reduce the symptoms associated with Alzheimer disease.

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

Namenda is Licensed from Merz Pharmaceuticals and its a registered trademark of Forest Laboratories.