DAYTON, N.J. — Aurobindo Pharma Ltd. has been cleared by the Food and Drug Administration to market hydrocodone bitartrate and ibuprofen tablets 7.5 mg/200 mg (C-II), a combination opioid and nonsteroidal anti-inflammatory drug (NSAID) painkiller.
Aurobindo said its combination hydrocodone/ibuprofen product is a generic version of Vicoprofen tablets from AbbVie Inc.
Hydrocodone bitartrate and ibuprofen tablets 7.5 mg/200 mg (C-II) are indicated for the short-term management of acute pain, typically for fewer than 10 days.
U.S. sales of hydrocodone bitartrate and ibuprofen tablets (7.5 mg/200 mg, C-II) totaled approximately $15.7 million for the 12 months ended in May, according to IMS Health data reported by Aurobindo.
