Aurobindo receives final FDA Approval for Hydrocodone Bitartrate and Ibuprofen Tablets (C-II)

Dayton, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg (C-II). The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg (C-II), to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Vicoprofen Tablets of AbbVie Inc.

Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg (C-II) is indicated for short-term (generally less than 10 days) management of acute pain.

The approved Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg (C-II) product has an estimated market size of $15.7M for the twelve months ending May 2016 according to IMS*.
Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg (C-II) represents the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 230 final approvals, including 39 tentative approvals and 13 from Aurolife Pharma LLC. There are 107 additional products on file with U.S. FDA.
* IMS National Sales Perspectives: Retail and Non-Retail MAT May 2016