Novartis Ritalin LA clears FDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Novartis adds second once-daily methylphenidate product with the June 5 approval of Ritalin LA, to be launched by the beginning of the 2002-2003 school year. The drug, developed using Elan's Spheroidal Oral Drug Absorption System (SODAS), has a bi-modal release, with half the dose in immediate-release beads and half in delayed-release beads that provide methylphenidate four hours later. Ritalin SR, in contrast, provides continuous drug release over eight hours. Ritalin LA will be available in 20 mg, 30 mg and 40 mg capsules that can be sprinkled onto applesauce, while Ritalin SR is available in 20 mg tablet
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Novartis adds second once-daily methylphenidate product with the June 5 approval of Ritalin LA , to be launched by the beginning of the 2002-2003 school year. The drug, developed using Elan's Spheroidal Oral Drug Absorption System (SODAS), has a bi-modal release, with half the dose in immediate-release beads and half in delayed-release beads that provide methylphenidate four hours later. Ritalin SR , in contrast, provides continuous drug release over eight hours. Ritalin LA will be available in 20 mg, 30 mg and 40 mg capsules that can be sprinkled onto applesauce, while Ritalin SR is available in 20 mg tablets |