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news.Forest Laboratories, a developer and marketer of both branded and generic forms of ethical drug products, and Cypress Bioscience, a provider of therapeutics and personalized medicine services, have announced that they expect to ship Savella, a selective serotonin and norepinephrine reuptake inhibitor for the management of fibromyalgia, to wholesalers and pharmacies by mid 2009.
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Savella (milnacipran HCl), was approved by the FDA on January 14, 2009 and was originally expected to be available in March 2009. The companies submitted a minor post-approval cosmetic formulation change for FDA approval. A response from the FDA is anticipated no later than May, 2009.
Savella will be marketed by Forest and its licensor, Cypress Bioscience. Pierre Fabre, who originally developed and sells milnacipran outside the US, licensed the rights for North America to Cypress Bioscience.