LOS ANGELES Aug 2 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