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Aurobindo gets FDA nod for dementia drug
City-based Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Rivastigmine Tartrate Capsules, indicated for the treatment of mild moderate dementia, in the American market.
Hyderabad: City-based Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Rivastigmine Tartrate Capsules, indicated for the treatment of mild moderate dementia, in the American market.
The company is gearing up to launch the product in the first quarter of next fiscal (FY17). “Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the USFDA to manufacture and market Rivastigmine Tartrate Capsules USP, 1.5 mg, 3 mg, 4.5 mg and 6 mg,” the drug maker said in a release.
The approved drug is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Exelon Capsules of Novartis Pharmaceuticals Corporation. The capsules 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 twelve months ending January 2016, according to IMS. This is the 67th ANDA (including 14 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products. Aurobindo now has a total of 246 ANDA approvals from USFDA.
