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The return to the USA of doxylamine-pyridoxine delayed release combination (Diclegis®) for morning sickness--a new morning for American women.

Abstract
The US FDA approval in April 2013 of Diclegis®, the doxylamine-pyridoxine combination for morning sickness, is a major milestone, particularly since it is indicated for use in pregnancy and the FDA has labeled it a pregnancy category A drug the strongest evidence of fetal safety. After thirty years of being orphaned from an FDA-labeled drug for the most common medical condition in pregnancy, American women and their health care providers have a therapeutic solution that is likely to positively impact millions of women each year. This review highlights the milestones of this antiemetic agent over the last 40 years.
AuthorsGideon Koren
JournalJournal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique (J Popul Ther Clin Pharmacol) Vol. 20 Issue 2 Pg. e161-2 ( 2013) ISSN: 2561-8741 [Electronic] Australia
PMID23863487 (Publication Type: Journal Article)
Chemical References
  • Antiemetics
  • Delayed-Action Preparations
  • Drug Combinations
  • dicyclomine, doxylamine, pyridoxine drug combination
  • Dicyclomine
  • Doxylamine
  • Pyridoxine
Topics
  • Antiemetics (adverse effects, therapeutic use)
  • Delayed-Action Preparations
  • Dicyclomine
  • Doxylamine (adverse effects, therapeutic use)
  • Drug Approval
  • Drug Combinations
  • Drug Labeling
  • Female
  • Humans
  • Morning Sickness (drug therapy, epidemiology)
  • Pregnancy
  • Pyridoxine (adverse effects, therapeutic use)
  • United States
  • United States Food and Drug Administration

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