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Daxxify FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 15, 2023.

FDA Approved: Yes (First approved September 7, 2022)
Brand name: Daxxify
Generic name: daxibotulinumtoxinA-lanm
Dosage form: Lyophilized Powder for Injection
Company: Revance Therapeutics, Inc.
Treatment for: Glabellar Lines, Cervical Dystonia

Daxxify (daxibotulinumtoxinA-lanm) is an acetylcholine release inhibitor and neuromuscular blocking agent for the temporary improvement of glabellar (frown) lines and the treatment of cervical dystonia.






Development timeline for Daxxify

Aug 15, 2023Approval FDA Approves First Therapeutic Indication for Revance‚Äôs Daxxify (daxibotulinumtoxinA-lanm) for Injection for the Treatment of Cervical Dystonia
Sep  8, 2022Approval FDA Approves Daxxify (daxibotulinumtoxinA-lanm) for Temporary Improvement of Moderate to Severe Glabellar Lines (Frown Lines)
Apr 21, 2022Revance Receives FDA Acceptance of BLA Resubmission for DaxibotulinumtoxinA for Injection for Glabellar Lines
Nov 25, 2020FDA Defers Approval of DaxibotulinumtoxinA for Injection in Glabellar Lines Due to COVID-19 Related Travel Restrictions Impacting Manufacturing Site Inspection

Further information

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