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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:  10/14/2008
Trade Name:  Zomig Nasal Spray
Generic Name or Proper Name (*):  zolmitriptan
Indications Studied:  Migraine
Label Changes Summary:  * Safety and effectiveness have not been established in pediatric patients less than18 years of age. * A single, multi-center, double-blind randomized placebo-controlled study failed to demonstrate efficacy in pediatric patients ages 12 -17 years for the acute treatment of migraine headaches * Adverse events similar to those observed in adults.
BPCA(B) and PREA(P):  B, P
Sponsor:  AstraZeneca
Pediatric Exclusivity Granted Date:  12/18/2003
Therapeutic Category:  Antimigraine