FDA Grants Marketing Clearance for Ritalin LA

Novartis Pharmaceuticals Corporation, Elan Corporation, plc, and Celgene Corporation announced today that the U.S. Food and Drug Administration (FDA) has granted marketing clearance for Ritalin® LA (methylphenidate HCl) extended-release capsules for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).

 Ritalin LA, a new once-daily formulation of Ritalin® (methylphenidate HCl), eliminates the need for a mid-day dose during school. Ritalin LA uses SODAS technology(1), a proprietary drug delivery technology of Elan. The medication is available in 20, 30 and 40 mg beaded capsules for oral administration.

“Ritalin LA represents an important advance in the treatment of ADHD,” said Thomas Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School and Assistant Director of the Pediatric Psychopharmacology Research Program at Massachusetts General Hospital. “It provides the rapid onset, and the proven safety and efficacy of Ritalin in one, single morning dose. Ritalin LA is effective in treating ADHD symptoms throughout the school day, eliminating the need for children to take their medication while in school.”

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