August 23, 2001 - Novartis and Celgene's Attention-Deficit Drug Clears an FDA Hurdle
WASHINGTON -- Novartis Pharmaceuticals Corp. and Celgene Corp. received an approvable letter from the Food and Drug Administration for Celgene's Ritadex, which is designed to treat symptoms of attention-deficit-hyperactivity disorder using half the dose of Ritalin.
Novartis Pharmaceuticals, a unit of Swiss-based Novartis AG, said the drug, which is called dexmethylphenidate, contains only the active isomer required for effective management of the symptoms of ADHD at half the dose of Ritalin. ADHD is a neurobiologic disorder that interferes with an individual's ability to regulate activity level and behavior.
The application that Novartis and Celgene submitted to the FDA contained data from six clinical trials that included 684 patients with ADHD, ages 6 to 17 years. In the trials, patients treated with Ritadex showed a significant improvement in performance and behavior associated with ADHD compared with those who were given a placebo. Overall, Novartis said, Ritadex was considered safe and well-tolerated in the trials.
An approvable letter usually represents the final step before a product receives FDA clearance for marketing in the U.S. Novartis licensed the world- wide marketing and development rights from Warren, N.J., drug maker Celgene. The rights exclude marketing in Canada.