FDA approves Luvox ER for anxiety and OCD

Belgian drugmaker Solvay says that US licensee Jazz Pharmaceuticals has received Food and Drug Administration approval for use of an extended-release formulation of its drug Luvox CR (fluvoxamine maleate) in mood disorders. Specifically, the drug has been cleared for social anxiety disorder and obsessive compulsive disorder.

Rights to Luvox CR, as well as those to an immediate-release formulation of the agent, were transferred to Jazz under a deal signed by the firms early last year (Marketletter February 12, 2007).

As a result of FDA approval, Jazz will pay Solvay $20.0 million as stipulated by the terms of the original agreement. The accord will also see Solvay transfer ownership of the Luvox New Drug Application to Jazz.