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Jazz submits complete responses for Luvox CR to FDA

US-based Jazz Pharmaceuticals, has said that the FDA accepted for review the NDA submission of the complete response by Solvay for its neurology treatment, Luvox CR (fluvoxamine) extended-release capsules.

US-based Jazz Pharmaceuticals, has said that the FDA accepted for review the NDA submission of the complete response by Solvay for its neurology treatment, Luvox CR (fluvoxamine) extended-release capsules.

The PDUFA action date is 22 December 2007.

The NDA for Luvox CR seeks marketing approval for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (OCD) and the treatment of social anxiety disorder (SAD).

The FDA has also accepted the submission of the complete response by Solvay Pharmaceuticals to the FDA approvable letter for Luvox (fluvoxamine) standard tablets. The PDUFA action date is 21 December 2007.

In January 2007, Jazz Pharmaceuticals licensed US marketing rights for Luvox CR and Luvox from Solvay Pharmaceuticals. Solvay retains the right to market both products in other territories around the world.

Subject to receipt of FDA approval, Jazz says it will launch Luvox CR in the US in Q1 2008.

Lehman Brothers say that Luvox CR sales should reach USD 170m in 2011 and USD 230m by 2015.

6th August 2007

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