From the News Desk of Jeanne Hambleton
Courtesy of Hays Pharma posted 09 Mar 2009
Forest Labs and Cypress Bioscience have delayed the release of its fibromyalgia treatment onto the market after it submitted a post-approval application to the US Food and Drug Administration (FDA).
The treatment, Savella, was originally expected to be shipped out to wholesalers and pharmacies in March, but the company now expects that it will be available in mid 2009.
Forest and Cypress have applied to the FDA for authorisation of a cosmetic formulation change and expects a response from the agency no later than May.
US health authorities originally approved the serotonin and norepinephrine reuptake inhibitor on January 14th for the management of fibromyalgia, a chronic condition characterised by widespread pain and reduced physical function.
A US court has recently filed a complaint against Forest, alleging that the company’s personnel falsely marketed the antidepressants Lexapro and Celexa and paid kickbacks to physicians to persuade them to prescribe the drugs.
Forest states that it is reviewing the allegations and will respond to the action at the appropriate time.