US drugmakers Forest Laboratories and Cypress Bioscience say that Savella (milnacipran HCl), their co-developed selective serotonin and norepinephrine dual reuptake inhibitor approved for the management of fibromyalgia, will be shipped to wholesalers on April 24 and will be available at pharmacies beginning on April 28. After Savella was approved by US regulators at the start of the year (Marketletter January 26), the companies submitted a minor post-approval cosmetic formulation change which has now been approved. The agent is a potential blockbuster with key differentiating characteristics as a treatment for this chronic condition, which affects as many as six million people in the USA. Its safety and efficacy was established in late-stage trials involving over 2,000 patients.
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