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.