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FDA Accepts Resubmitted NDA for Selegiline Antidepressant Patch
The amendment to the New Drug Application includes additional clinical data evaluating the safety and efficacy of EMSAM™ at 20mg, 30mg and 40mg doses as compared to placebo. In addition, results from a 1 year relapse study and supplemental safety studies were submitted. The FDA has provided an action date of February 1, 2004.
Source: Mylan Laboratories Inc. and Watson Pharmaceuticals, Inc.