Dayton, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Ibandronate Sodium Tablets, 150 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Ibandronate Sodium Tablets, 150 mg, to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), BONIVA® of Hoffmann-La Roche Inc. (Roche).
Ibandronate Sodium Tablets, 150 mg, is a Calcium Regulator. It is indicated for the treatment and prevention of osteoporosis in post-menopausal women.
The product has an estimated market size of $55.1M for the twelve months ending January 2016, according to IMS*.
Ibandronate Sodium Tablets represents the latest addition to Aurobindo’s broad line of vertically integrated pharmaceuticals. Aurobindo’s product portfolio consists of 208 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 January 2016