Dysport FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 28, 2021.
FDA Approved: Yes (First approved April 29, 2009)
Brand name: Dysport
Generic name: abobotulinumtoxinA
Dosage form: Injection
Company: Ipsen Biopharmaceuticals, Inc.
Treatment for: Cervical Dystonia, Facial Wrinkles, Upper Limb Spasticity, Lower Limb Spasticity
Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for:
- the treatment of cervical dystonia in adults
- the temporary improvement in the appearance of moderate to severe
glabellar lines associated with procerus and corrugator muscle
activity in adults < 65 years of age
- the treatment of spasticity in patients 2 years of age and older.
Development timeline for Dysport
|Jul 9, 2020||Approval Ipsen Announces Updated Indication for Dysport (abobotulinumtoxinA) for the Treatment of Spasticity in Children|
|Jun 16, 2017||Approval Ipsen Announces FDA approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults|
|Aug 1, 2016||Approval 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||Approval Ipsen Announces FDA Approval of Dysport (abobotulinumtoxinA) for Upper Limb Spasticity|
|Apr 30, 2009||Approval FDA Approves Dysport (abobotulinumtoxinA) for Cervical Dystonia and Glabellar Lines|
|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 Aesthetics by FDA|
|Mar 17, 2008||Ipsen and Medicis Announce Submission of Reloxin BLA in Aesthetics 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 to the FDA|
|Dec 6, 2007||Ipsen Submits a Biologics License Application in Cervical Dystonia
to the FDA for Dysport|
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