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, Upper Limb Spasticity, Spinal Spasticity

Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent for the treatment of cervical dystonia, for the temporary improvement in the appearance of moderate to severe glabellar lines, upper limb spasticity in adults, and lower limb spasticity in pediatric patients.

Development History and FDA Approval Process for Dysport

Date	Article
Aug  1, 2016	Ipsen Biopharmaceuticals, Inc. Announces FDA Approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Pediatric Patients Aged Two and Older
Jul 17, 2015	Ipsen Announces FDA Approval of Dysport (abobotulinumtoxinA) for Upper Limb Spasticity
Apr 30, 2009	FDA Approves Dysport for Therapeutic and Aesthetic Uses
Dec 29, 2008	FDA Issues Complete Response Letter to Ipsen for Dysport Biologics License Application
May 19, 2008	Ipsen and Medicis Announce Acceptance of Reloxin BLA in Aestheticsby FDA
Mar 17, 2008	Ipsen and Medicis announce submission of Reloxin BLA inaesthetics to the FDA
Jan 31, 2008	Ipsen: FDA Accepts for Filing a Biologics License Application (BLA) for Dysport in Cervical Dystonia
Dec  6, 2007	Ipsen and Medicis Announce Submission of Reloxin in Aesthetics tothe FDA
Dec  6, 2007	Ipsen Submits a Biologics License Application in Cervical Dystonia to the FDA for Dysport

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