ARTICLE | Clinical News

Oleptro trazodone regulatory update

November 22, 2010 8:00 AM UTC

Labopharm said it received notice from Actavis South Atlantic LLC, a subsidiary of Actavis Group (Hafnarfjordur, Iceland), that the subsidiary submitted a Paragraph IV certification to FDA as part of an ANDA for generic Oleptro trazodone. Oleptro, an extended-release formulation of the serotonin antagonist reuptake inhibitor (SARI), is marketed in the U.S. to treat major depressive disorder (MDD). Labopharm is currently reviewing the letter to determine its next steps. ...