FDA approves Par generic obsessive compulsive disorder drug

Par receives 180 days of market exclusivity as first filer

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

Par announced the approval and shipment of fluvoxamine maleate extended-release capsules in the 100-mg and 150-mg strengths. The drug is a generic version of Jazz Pharmaceuticals' Luvox CR.

Par said it was the first company to file a complete regulatory approval application for a generic version of the drug, thus entitling it to 180 days of market exclusivity in which to compete directly with the branded drug. Luvox CR has annual sales of about $51 million, according to IMS Health.


Login or Register to post a comment.