US-based pharmaceutical company Forest Laboratories, and Cypress Bioscience have said that they expect to ship Savella(TM) (milnacipran HCl), a selective serotonin and norepinephrine reuptake inhibitor for the management of fibromyalgia, to wholesalers and pharmacies by mid 2009.
 
Savella was approved by the US Food and Drug Administration (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 is approved for the management of fibromyalgia; a chronic condition characterized by widespread pain and decreased physical function that afflicts as many as six million people in the United States.
 
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.