Aurobindo Pharma gets ANDA approval for Rivastigmine Tartrate Capsules

From USFDA

Aurobindo Pharma 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. This 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 US$ 26.7 million for the twelve months ending January 2016 according to IMS.

 

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