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
| Date | Article |
|---|
| 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 |
Further information
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