Aurobindo earns FDA approval for multiple sclerosis generic


EAST WINDSOR, N.J. — The U.S. Food and Drug Administration approved Aurobindo Pharma’s Dalfampridine Extended-Release tablets, 10 mg, intended for treatment of multiple sclerosis.

The FDA’s Division of Bioequivalence determined the Aurobindo drug to be bioequivalent, and therefore therapeutically equivalent to the referenced listed drug, Amprya from Acorda Therapeutics.

According to QuintilesIMS, the Aurobindo product has an estimated market size of $347 million for the 12 months ended November 2016.

Aurobindo’s portfolio of generic pharmaceuticals includes 256 final FDA approvals, including 39 tentative approvals, and 16 approved products from Aurolife. There are 97 additional product on file with the FDA.

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