The US Food & Drug Administration (FDA) has granted final approval to Aurobindo Pharma Limited for manufacturing and marketing tramadol hydrochloride extended-release tablets (100 mg, 200 mg and 300 mg), which are generic version of Valeant’s UltraM ER tablets. The company aims to launch this product 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. According to IMS, the approved product has an estimated market size of $ 56 million for the twelve months ending August 2015.
