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Commercial availability of FDA-approved fibromyalgia drug Savella™ moved up to April 28

  [ 6 votes ]   [ Discuss This Article ] • April 21, 2009

Forest Laboratories, Inc. and Cypress Bioscience, Inc. announced Monday, April 20 that Savella(TM) (milnacipran HCl), a selective serotonin and norepinephrine dual reuptake inhibitor that received FDA approval on Jan 14 for the management of fibromyalgia, will be shipped to wholesalers on April 24th and will be available at pharmacies beginning on April 28th.

After Savella’s January approval, the companies submitted a minor post-approval cosmetic formulation change to the FDA. And though they initially predicted approval and market launch in mid-2009, the reformulation is already approved.

According to the makers, “Savella is a dual-reuptake inhibitor that, in-vitro, preferentially blocks the reuptake of norepinephrine with higher potency than serotonin, two neurotransmitters thought to a play a central role in the symptoms of fibromyalgia.”

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