Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market tramadol hydrochloride extended-release tablets USP, 100 mg, 200 mg and 300 mg (ANDA 204421). This product will be launched by Q4 FY 2015-16.
The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) ULTRAM ER (Tramadol Hydrochloride) extended-release tablets 100 mg, 200 mg and 300 mg of Valeant INTL.
Tramadol hydrochloride extended-release tablets are used in the treatment of moderate-to-severe pain in adults who require around-the-clock treatment for an extended period of time. The approved product has an estimated market size of $56 million for the twelve months ending August 2015 according to IMS.
This is the 50th ANDA to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products. Aurobindo now has a total of 217 ANDA approvals (189 final approvals including 10 from Aurolife Pharma and 28 tentative approvals) from US FDA.
