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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
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Pediatric Labeling Date:  09/10/2014
 
Trade Name:  Emsam
 
Generic Name or Proper Name (*):  selegiline
 
Indications Studied:  Treatment of major depressive disorder
 
Label Changes Summary:  Multi-center, randomized, double-blind, placebo-controlled, flexible-dose trial in 308 adolescents 12 – 17 years failed to demonstrate efficacy Emsam should not be used in patients less than 18 years. Use in patients less than 12 years is contraindicated because of the potential for a hypertensive crisis, which may be increased compared to adolescents and adults based on limited PK data suggesting higher exposure even at the lowest dose Adverse events were similar to those observed in adults Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Somerset Pharmaceuticals, Inc.
 
NNPS:  FALSE'
 
Therapeutic Category:  Antidepressant
 
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