Generic Severe Chronic Pain Treatment Launched
Generic tramadol hydrochloride extended-release tablets treat moderate to moderately severe chronic pain.
Mylan is launching tramadol hydrochloride extended-release tablets—a generic version of Valeant’s Ultram extended-release tablets.
The FDA approved Mylan’s abbreviated new drug application for the product, which can be used to treat moderate to moderately severe chronic pain in adults who need around-the-clock pain treatment for an extended period of time.
Mylan also has 265 abbreviated new drug applications pending FDA approval.
Tramadol hydrochloride extended-release tablets USP, 100 mg, 200 mg, and 300 mg, brought in US sales of around $52.8 million in 2015, according to IMS Health.
Aurobindo Pharma Limited also announced back in October 2015 that it had received final approval from the FDA to manufacture and market a generic version of Ultram.