FDA has accepted Solvay Pharmaceuticals' complete response to a February "approvable" letter for Luvox CR (fluvoxamine maleate) extended-release capsules, U.S. marketing partner Jazz Pharmaceuticals announced Aug. 2.

The action date on the NDA, which was initially submitted in April 2006, is now Dec. 22, 2007, Jazz said. The "approvable" letter requested additional toxicology studies on impurities associated with the drug's active ingredient, fluvoxamine maleate.

Solvay is seeking approval to market the selective serotonin reuptake inhibitor for the treatment of social anxiety disorder and the obsessions and compulsions of obsessive compulsive disorder. Jazz has said it hopes to begin promoting the product in the first quarter of 2008.

FDA also accepted Solvay's complete response to an "approvable" letter for Luvox in immediate-release tablet form. Solvay withdrew immediate-release Luvox from the U.S. market in 2002 due to manufacturing compliance and recordkeeping issues, and an NDA seeking market re-entry was deemed "approvable" in February 2004. The NDA now has a Dec. 21, 2007, action date, Jazz said.

In February, Jazz and Solvay, which has its U.S. headquarters in Marietta, Ga., announced a licensing deal under which Palo Alto, Calif.-based Jazz will market both the extended-release and immediate release forms of the SSRI in the U.S. Solvay retained rest-of-the-world rights.

Jazz, which has been in business since 2003, made its initial public offering in June with the goal of raising more than $100 million to help fund commercialization of Luvox CR. The firm offered six million shares of its common stock at a price of $18 per share.

The firm's marketed product Xyrem (sodium oxybate) is licensed to UCB, in Brussels, Belgium, for commercialization in Europe and to Valeant, in Aliso Viejo, Calif., for Canada. Xyrem is a Schedule III drug under the Controlled Substances Act.

Jazz is testing a liquid Xyrem formulation, known as JZP-6, in two Phase III pivotal trials for the treatment of fibromyalgia syndrome. It is currently approved for the treatment of cataplexy and excessive daytime sleepiness in patients with narcolepsy.

- Shirley Haley (s.haley@elsevier.com)

Jazz Hits A High Note With Luvox Resubmissions

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