Dayton, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Rivastigmine Tartrate Capsules USP, 1.5 mg, 3 mg, 4.5 mg and 6 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Rivastigmine Tartrate Capsules USP, 1.5 mg, 3 mg, 4.5 mg and 6 mg to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Exelon® of Novartis Pharmaceuticals Corporation (Novartis).
Rivastigmine Tartrate Capsules USP is indicated in the treatment of mild to moderate dementia of the Alzheimer’s type and mild to moderate dementia associated with Parkinson’s disease.
The product has an estimated market size of $26.2M for the twelve months ending February 2016 according to IMS*.
Rivastigmine Tartrate Capsules USP, 1.5 mg, 3 mg, 4.5 mg and 6 mg represents the latest addition to Aurobindo’s broad line of vertically integrated pharmaceuticals. Aurobindo’s product portfolio consists of 210 final approvals, including 33 tentative approvals and 10 from Aurolife Pharma LLC. There are 120 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT February 2016