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Celgene/Novartis dexmethylphenidate

Executive Summary

Approval of dexmethylphenidate, a single-isomer version of Novartis' attention deficit hyperactivity disorder drug Ritalin, is expected within six to eight weeks pending labeling negotiations, Celgene said Aug. 21 following "approvable" letter from FDA. Celgene and Novartis, which will market the product, have proposed the trade name Ritadex (formerly Ritalin-D). Novartis filed an NDA for a once-daily methylphenidate modified-release capsule Ritalin LA on Nov. 29, 2000 and is predicting a fourth quarter approval
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