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: Allergan plc
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.
- 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
Further information
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