Dec 21 Jazz Pharmaceuticals Inc (JAZZ.O) said the U.S. health regulator, Food and Drug Administration, needs more information before it approves the company's mental disorder drug, Luvox, for treatment of social anxiety disorder.
Jazz, which is developing the drug with Belgian drug maker Solvay Pharmaceuticals Inc (SOLB.BR), said it was issued an "approvable letter" which did not raise any questions related to safety or efficacy of the drug.
The approvable letter included the FDA's proposed labeling, Jazz said in a statement. The drug was approved for the treatment of obsessive compulsive disorder on December 20, 2007 . (Reporting by Varsha Tickoo in Bangalore)