Once-daily Ritalin product receives FDA approvable letter

מתוך medicontext.co.il

NEW YORK (Reuters Health) – Novartis Pharmaceuticals Corp. and Celgene Corp. announced on Tuesday that they have received an approvable letter from the US Food and Drug Administration for a once-daily version of Novartis' attention deficit/hyperactivity disorder (ADHD) drug Ritalin (methylphenidate).

A spokeswoman for Warren, New Jersey-based Celgene told Reuters Health that the new drug, called Ritalin LA (methylphenidate HCl extended-release capsules), employs a newer technology that allows for a more rapid onset of action compared with Ritalin SR, which has been available since 1982. She added that the company has no plans at this time to phase out the earlier product.

Currently, there are two once-daily treatments for ADHD available in the US: Alza's Concerta and Celltech's Metadate, both of which have methylphenidate as their active ingredient. In August, Shire Pharmaceuticals received an approvable letter for its once-daily ADHD treatment Adderall (amphetamine/dextroamphetamine

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