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Jazz Pharma says FDA accepts additional data on Luvox
January 31, 2008 / 9:57 PM / 10 years ago

Jazz Pharma says FDA accepts additional data on Luvox

Jan 31 (Reuters) - Jazz Pharmaceuticals Inc (JAZZ.O) said the U.S. Food and Drug Administration has accepted for review the additional data on its mental disorder drug, Luvox, for treatment of social anxiety disorder.

In December, the U.S. health regulator issued an approvable letter for the drug and requested for additional information. The letter did not raise any questions related to safety or efficacy of Luvox and included the FDA’s proposed labeling.

The FDA has set Feb. 29 as the action date for the drug, which Jazz developed with Belgian drug maker Solvay Pharmaceuticals Inc (SOLB.BR), the company said in a statement. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Deepak Kannan)

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