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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Somerset Pharmaceuticals, Inc.
NNPS:
FALSE'
Therapeutic Category:
Antidepressant
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