Savella, the newest drug to receive FDA approval for the treatment of fibromyalgia, was supposed to be available in pharmacies sometime this month (March 2009). However, Forest Laboratories, Inc. and Cypress Bioscience, Inc., manufacturers of Savella, announced Friday that the delivery date of Savella will now be sometime in mid-2009.
The reason given was that the companies submitted a minor post-approval cosmetic formulation change to the FDA for approval. They're expecting a response from the FDA no later than May 2009. They don't say why the cosmetic change was necessary.
Savella (generic name milnacipran) has been prescribed as an antidepressant in other countries for some time, however, this is the first time it has been approved for any use in the U.S. Because of this, the only people who have tried Savella in the U.S. are those who participated in its clinical trials.
If you'd like to know more about Savella, read “FDA Approves Third Medication for Fibromyalgia”
Published On: March 07, 2009