Unichem gets tentative nod from USFDA for dementia tablets

NEW DELHI: Drug firm Unichem Laboratories today said it has received tentative approval from the US health regulator for its Memantine Hydrochloride tablets used for treating dementia due to Alzheimer's disease.

"Final approval will be received after the patent expires on April 11, 2015," it added.

The company has received tentative approval from the United States Food and Drug Administration ( USFDA) for Memantine Hydrochloride tablets in the strengths of 5 mg and 10 mg, Unichem Laboratories said.

The tablets are generic equivalent to Forest Laboratories Inc's Namenda tablets in the same strengths, it added.

"Memantine Hydrochloride is used to treat moderate to severe dementia of the Alzheimer's type. Further, it reduces the actions of chemicals in the brain that may contribute to the symptoms of Alzheimer's disease," Unichem said

The product will be commercialised from Unichem's Goa plant, it added.

Unichem Laboratories has a strong presence in niche therapy areas of cardiology, neurology, orthopaedics and anti -infectives.

Shares of Unichem Laboratories today closed at Rs 185 per scrip on BSE, down 1.41 per cent from its previous close.