Novartis Focalin ADHD approval
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Focalin (dexmethylphenidate), the single-isomer version of Ritalin, is approved Nov. 13 for treatment of attention deficit hyperactivity disorder. The 2.5 mg, 5 mg and 10 mg tablets are expected to be available by the end of January. Novartis had planned to use the tradename Ritadex, but FDA was concerned about prescribing errors due to potential confusion with Ritalin. Novartis acquired worldwide marketing rights to dexmethylphenidate (except in Canada) from Celgene in April 2000