Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Tramadol Hydrochloride Extended -release Tablets USP, 100 mg, 200 mg and 300 mg.
This product will be launched by Q4 FY 2015-16. 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 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, Aurobindo Pharma said in a press release.
This is the 50th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products.
Subscribe to PharmaTutor News Alerts by Email >>
