Wendy future of retail top

Aurobindo generic of Ultram ER OK’d by FDA

Print Friendly, PDF & Email

DAYTON, N.J. — Aurobindo Pharma Ltd. has received final approval from the Food and Drug Administration for tramadol hydrochloride extended-release tablets, an opioid pain medication (Class IV), in dosages of 100 mg, 200 mg and 300 mg.

Aurobindo said Tuesday that the FDA’s Division of Bioequivalence has determined that the company’s tramadol hydrochloride ER product are therapeutically equivalent to the referenced listed drug, Ultram ER tablets (100 mg, 200 mg and 300 mg) from Valeant International.

Tramadol hydrochloride ER tablets are indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of pain for an extended time period.

The drug had total U.S. sales of about $64.4 million for the 12 months through August 2015, according to IMS Health data reported by Aurobindo.


ECRM_06-01-22


Comments are closed.

Centrum 7/6  banner