Mylan launches generic of Valeant’s Ultram in the US
pharmafile | March 29, 2016 | News story | Manufacturing and Production, Sales and Marketing | FDA, Mylan, Valeant, abbreviate new drug application, generic, pain, tramadol, ultram
Mylan (NASDAQ, TASE: MYL) has announced the launch of its generic version of Valeant’s Ultram tablets in the US.
The company received final approval from the US Food and Drug Administration for its tramadol hydrochloride extended-release tablets USP, which is indicated for the management of moderate to moderately severe chronic pain in adults who require around-the-clock treatment of their pain for an extended period of time.
According to IMS Health, tramadol hydrochloride extended-release tablets USP had US sales of approximately $52.8 million for the 12 months to 31st December 2015.
Mylan currently has 265 abbreviate new drug applications pending FDA approval, which represent £110.3 billion in annual brand sales, according to the research body.
Sean Murray
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