FDA issues Luvox CR approvable letter

Jazz (JAZZ) and Solvay (Euronext:SOLB) received a second approvable letter for Luvox CR extended-release formulation of fluvoxamine to treat obsessive compulsive disorder (OCD) and social anxiety disorder. JAZZ said FDA requested information concerning the companies' response to a previously disclosed CMC issue. JAZZ also disclosed that on Thursday FDA approved Luvox immediate-release formulation to treat OCD. In August, FDA accepted complete responses to approvable letters covering both formulations of the selective serotonin reuptake inhibitor (SSRI) (See BioCentury Extra, Thursday, Aug. 02, 2007).

JAZZ has U.S. marketing rights to the products. SOLB pulled Luvox from the U.S. market in 2002 due to issues with the CMC section of the product's NDA (See BioCentury Extra, Thursday, May 23, 2002). ...