Aurobindo Pharma has received final approval from USFDA to manufacture and market Rivastigmine Tartrate Capsules USP, used for the treatment of dementia disease, in the American market.
“The company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Rivastigmine Tartrate Capsules USP, 1.5 mg, 3 mg, 4.5 mg and 6 mg,” Aurobindo Pharma said in a BSE filing.
The company said this product is expected to be launched in the first quarter of next fiscal.
The approved product is bioequivalent and therapeutically equivalent to Novartis Pharmaceuticals Corporation’s Exelon Capsules, it added.
According to IMS, the approved product has an estimated market size of $26.7 million for the 12-month period ended January 2016, Aurobindo Pharma said.
Exelon is used in the treatment of mild moderate dementia of the Alzheimer’s and Parkinson’s disease.
Aurobindo Pharma currently has 246 ANDA approvals (211 final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from the US.
Aurobindo Pharma shares were trading 3.58 per cent lower at Rs 719 apiece during late morning session on BSE.