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Ubrelvy FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

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

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

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
Feb  6, 2018Allergan Announces Positive Top Line Phase 3 Results for Ubrogepant - an Oral CGRP Receptor Antagonist for the Acute Treatment of Migraine

Further information

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