mylan_plus_hero_720x510

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.

Advertisement

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

Related Content

Rethinking oncology trial endpoints with generalised pairwise comparisons

For decades, oncology trials have been anchored to a familiar set of endpoints. Overall survival …

brain_anatomy_medical_head_skull_digital_3_d_x_ray_xray_psychedelic_3720x2631_1

Alto Neuroscience’s schizophrenia treatment granted FDA Fast Track designation

Alto Neuroscience has announced that its investigational treatment for cognitive impairment associated with schizophrenia (CIAS) …

FDA approves Moderna’s updated COVID-19 vaccines targeting new variant

FDA approves Moderna’s updated COVID-19 vaccines targeting new variant

The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and …

The Gateway to Local Adoption Series

Latest content