Unichem laboratories has received ANDA tentative approval from the United States Food and Drug Administration (US FDA) for Memantine Hydrochloride Tablets. Final approval for the product will be received by the company after the patent expires on April 11, 2015.
Memantine Hydrochloride Tablets 5mg and 10mg are therapeutically equivalent to NAMENDA Tablets 5mg and 10mg of Forest Laboratories Inc. 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.
The product will be commercialized from Unichem’s GOA plant. Active pharmaceutical ingredient i.e. Memantine Hydrochloride used for this ANDA is also made in house at Pithampur plant.
