Meda announces FDA approval for Soma 250mg

Meda has announced that its skeletal muscle relaxant, Soma (carisoprodol) 250mg, has been approved by the US Food and Drug Administration (FDA).

The Swedish company has seen Soma become a well-established brand in the US, generating around ten million prescriptions a year for the drug which is indicated for treatment of painful musculoskeletal conditions such as backache.

Soma 250mg will now be the only available low-dose treatment of carisoprodol and has been granted a minimum three-year exclusivity period in the US with the launch starting immediately.

“The clinical benefits of Soma 250mg are in line with current treatment strategies for back pain which focuses on helping patients to return to normal physical activity as quickly as possible,” said Lee Ralph, lead author and investigator for the Soma 250mg clinical trials.

Last year, Meda took over 3M’s drug business, paying $857 million (?427 million).