Hyderabad-based Aurobindo Pharma Limited has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market rivastigmine tartrate capsules USP in 1.5 mg, 3 mg, 4.5 mg and 6 mg strengths.
A bioequivalent and therapeutically-equivalent to the reference listed drug product Exelon Capsules of Novartis Pharmaceuticals Corporation, the tablets are used in the treatment of mild moderate dementia of the Alzheimer's and Parkinson's disease.
The approved product has an estimated market size of $26.7 million for the 12 months ending January 2016. The product is expected to be launched in the first quarter of the ensuing financial year, Aurobindo said in a filing to the BSE on Tuesday.
Aurobindo Pharma's scrip is currently trading at Rs 720 on the BSE, down 3.45%, over the previous close of Rs 745.70 per share.