Dysport Approval History

  • FDA approved: Yes (First approved April 29th, 2009)
  • Brand name: Dysport
  • Generic name: abobotulinumtoxinA
  • Company: Medicis and Ipsen
  • Treatment for: Cervical Dystonia, Facial Wrinkles

Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent for the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain, and for the temporary improvement in the appearance of moderate to severe glabellar lines.

FDA Approval History for Dysport

DateArticle
Apr 30, 2009Approval FDA Approves Dysport for Therapeutic and Aesthetic Uses
Dec 29, 2008FDA Issues Complete Response Letter to Ipsen for Dysport Biologics License Application
Jan 31, 2008Ipsen: FDA Accepts for Filing a Biologics License Application (BLA) for Dysport in Cervical Dystonia
Dec  6, 2007Ipsen Submits a Biologics License Application in Cervical Dystonia to the FDA for Dysport

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