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Jazz says Solvay gives FDA more Luvox information
August 2, 2007 / 9:49 PM / 10 years ago

Jazz says Solvay gives FDA more Luvox information

LOS ANGELES, Aug 2 (Reuters) - Jazz Pharmaceuticals (JAZZ.O) said on Thursday that partner Solvay Pharmaceuticals (SOLB.BR) has fully responded to U.S. regulators’ information request regarding its bid to sell Luvox CR extended-release capsules as a treatment for two mental disorders.

Jazz said a decision on marketing approval for Luvox CR, or fluvoxamine maleate, as a treatment for obsessive compulsive disorder and social anxiety disorder is expected from the U.S. Food and Drug Administration (FDA) by Dec. 22.

The company, which is also seeking FDA approval for Luvox immediate release tablets, said Solvay responded to the FDA’s information request and expects a decision by Dec. 21.

Fluvoxamine maleate belongs to a class of antidepressants known as selective serotonin reuptake inhibitors. Jazz has licensed rights to market Solvay’s Luvox CR and Luvox in the United States.

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