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Aurobindo Pharma receives US FDA approval for rivastigmine tartrate capsules

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The product is expected to be launched in Q1 FY16-17

Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market rivastigmine tartrate capsules USP, 1.5 mg, 3 mg, 4.5 mg and 6 mg. The product is expected to be launched in Q1 FY16-17.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Exelon capsules, 1.5 mg, 3 mg, 4.5 mg and 6 mg, of Novartis Pharmaceuticals Corporation.

Naproxen sodium tablets is 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, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 246 ANDA approvals (211 Final approvals including 10 from Aurolife Pharma LLC and 35 tentative approvals) from US FDA.

EP News BureauMumbai

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