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Somerset Emsam NDA Resubmission Adds Long-Term Indication, Higher Doses

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Somerset’s resubmitted NDA for the selegiline patch Emsam seeks an indication for relapse prevention as well as treatment of depression.

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Somerset Emsam "approvable

Somerset receives "approvable" letter Jan. 30 for its transdermal selegiline patch, Emsam. The Mylan/Watson joint venture indicated that FDA is requesting additional pharmacology/toxicology studies as well as postmarketing pharmacokinetic and safety studies. Tyramine dietary restrictions in labeling are also requested. The sponsors resubmitted the Emsam NDA Aug. 1, 2003 for treatment of depression following a March 2002 "not approvable" letter (1Pharmaceutical Approvals Monthly Sept. 1, 2003, p. 14)...

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