Unichem receives tentative nod from USFDA for dementia tablets
The drug firm has received a tentative approval from USFDA for its Memantine Hydrochloride tablets.
New Delhi, October 29, 2012: Unichem Laboratories has received a tentative approval from the US Food and Drug Administration (USFDA) for its Memantine Hydrochloride tablets used for treating dementia due to Alzheimer's disease. It is worth noting here that the company will receive the final approval only after the patent expires in April 2015.
“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,” the company said in a statement. The tablets are generic equivalent to Forest Laboratories Inc's Namenda tablets in the same strengths.
The company also said that the product will be commercialised from Unichem’s Goa plant. The company already has a strong presence in segments like cardiology, neurology, orthopaedics and anti–infectives.