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Home > Research Articles > Once-a-day Ritalin formulation wins FDA OK

Reuters Health

Sunday, June 9, 2002

06/06/2002 - Once-a-day Ritalin formulation wins FDA OK WASHINGTON (Reuters Health) - The US Food and Drug Administration (FDA) has approved the marketing of a once-a-day formulation of the drug Ritalin, which is used to treat attention-deficit/hyperactivity disorder (ADHD), Novartis Pharmaceuticals Corp. announced Thursday. ADHD, characterized by developmentally inappropriate impulsivity, inattention and hyperactivity, affects 3% to 5% of school-age children. The new drug formulation, Ritalin LA, was developed by Ireland's Elan Corporation plc. It is expected to eliminate the need for children to take a midday dose at school, Novartis said. Novartis has offered a twice-daily formulation of Ritalin since 1982. Ritalin LA will be offered in capsules and beads that can be sprinkled on food for children who have difficulty swallowing, the company said. The drug is not the first once-daily treatment for ADHD to be available in the US. Others include Johnson & Johnson's Concerta, Celltech Pharmaceuticals' Metadate CD and Shire Pharmaceuticals' Adderall XR. Novartis spokeswoman Denise Brashear told Reuters Health the once-a-day formulation would be launched prior to the 2002 school year. But Brashear said Novartis does not anticipate a significant increase in new patient starts. Instead, the new formulation is expected to offer existing patients another treatment option. Recent figures have shown that about 30% of patients have migrated to once-a-day formulations, suggesting that these medications are filling a need, she added.