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Ubrelvy FDA Approval History

FDA Approved: Yes (First approved December 23, 2019)
Brand name: Ubrelvy
Generic name: ubrogepant
Dosage form: Tablets
Company: Allergan plc
Treatment for: Migraine, Chronic Migraine

Ubrelvy (ubrogepant) is a potent, orally-administered CGRP receptor antagonist for the acute treatment of migraine with or without aura in adults.

  • The recommended dose of Ubrelvy is 50 mg or 100 mg taken orally, as needed. A second dose may be administered at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg.
  • Ubrelvy should not be used with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin).
  • Common adverse reactions include nausea (4%) and somnolence (3%).

Development Timeline for Ubrelvy

DateArticle
Dec 23, 2019Approval  FDA Approves Ubrelvy (ubrogepant) for the Acute Treatment of Migraine
Dec  4, 2019Allergan Announces Positive Phase 3 Achieve I Trial Results for Ubrogepant Published in the New England Journal of Medicine
Nov 19, 2019Allergan Announces Positive Phase 3 ACHIEVE II Trial Results for Ubrogepant Published in The Journal of the American Medical Association
Mar 11, 2019Allergan Announces FDA Acceptance of New Drug Application for Ubrogepant for the Acute Treatment of Migraine
Apr 27, 2018Allergan Announces Second Positive Phase 3 Clinical Trial for Ubrogepant -- an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.