Jazz, Solvay receive approvable letter from FDA regarding extended-release Luvox

PALO ALTO, Calif. The Food and Drug Administration issued an approvable letter for Jazz Pharmaceuticals’ Once-a-Day Luvox CR (fluvoxamine maleate), which the company is trying to market as an extended-release capsule indicated for the treatment of social anxiety disorder and obsessive compulsive disorder.

Jazz has teamed up with Solvay Pharmaceuticals to market the drug. The FDA earlier this month approved the regular formulation of Luvox for the treatment of OCD.

The companies are seeking clarification from the FDA and look forward to working with the FDA to resolve any issues as quickly as possible. They stressed that the approvable letter did not raise any questions related to the safety or efficacy of Luvox CR.