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Noven Pharmaceuticals cited for drug patch's faulty release liners

This article was originally published in The Gold Sheet

Executive Summary

FDA issued a warning letter on Jan. 4 to Noven Pharmaceuticals of Miami, Fla, where the firm manufacturers its Daytrana (methylphenidate) patch for attention deficit/hyperactivity disorder. During inspections in June and July 2007, FDA observed a failure to establish scientifically sound and appropriate specifications, standards and test procedure designed to assure that the drug products conform to appropriate standards of identity, strength, quality and purity. For example, a liner release force specification had not been established for the patch at the time of the inspection

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