Novartis Ritalin LA becomes "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Novartis receives "approvable" letter Oct. 1 for once-daily Ritalin LA (methylphenidate) for attention deficit hyperactivity disorder. The company anticipates approval of the NDA, submitted November 2000, in the fourth quarter. Novartis is also awaiting final approval of a single-isomer version of Ritalin (dexmethylphenidate) licensed from Celgene, which was found"approvable" Aug. 21. Ritadex is the proposed name for that product