Dysport FDA Approval History
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
Last updated by Judith Stewart, BPharm on Jan 28, 2021.
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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