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Ajovy FDA Approval History

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

FDA Approved: Yes (First approved September 14, 2018)
Brand name: Ajovy
Generic name: fremanezumab-vfrm
Dosage form: Injection
Company: Teva Pharmaceuticals USA, Inc.
Treatment for: Migraine Prevention

Ajovy (fremanezumab) is a fully-humanized monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) ligand indicated for the preventive treatment of migraine.

Development timeline for Ajovy

Jan 28, 2020Approval Teva Announces FDA Approval of Ajovy (fremanezumab-vfrm) Injection Autoinjector
Sep 14, 2018Approval FDA Approves Ajovy (fremanezumab-vfrm) for Preventive Treatment of Migraine
Jun 15, 2018Teva Provides Update on Clinical Trial of Fremanezumab for Use in Chronic Cluster Headache
May 23, 2018Teva Confirms September PDUFA Date for Fremanezumab
May 15, 2018Teva Announces Publication of Phase III Trial Data of Fremanezumab for the Preventive Treatment of Episodic Migraine in the Journal of the American Medical Association
Dec 18, 2017FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program
Oct 17, 2017Teva Announces Submission of Biologics License Application for Fremanezumab to the U.S. FDA
Jun  7, 2017Teva's Fremanezumab Meets all Primary & Secondary Endpoints Across Both Monthly and Quarterly Dosing Regimens in Phase III Study in Episodic Migraine Prevention
May 31, 2017Teva Announces Positive Results for Phase III Study of Fremanezumab for the Prevention of Chronic Migraine

Further information

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