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Shire resubmits methylphenidate patch

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Shire and partner Noven's response to an April 2003 "not approvable" letter for their methylphenidate transdermal patch for attention deficit hyperactivity disorder has been accepted by FDA, the firms announce July 26. The NDA was resubmitted June 28. Included in the submission are two additional studies: a 270-patient Phase III trial and a 79-patient Phase II trial. Both studies were seven weeks and enrolled children between six and 12 years of age. The sponsors are seeking an indication for treatment of that age group in the new NDA. The product, formerly MethyPatch, would be the first methylphenidate product available in patch form...

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