Dysport 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
Dysport (abobotulinumtoxinA) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment of cervical dystonia, for the temporary improvement in the appearance of moderate to severe glabellar lines, for the treatment of spasticity in adults, and the treatment of lower limb spasticity in pediatric patients.
Development History and FDA Approval Process for Dysport
|Jun 16, 2017|| Ipsen Announces FDA approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults|
|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 (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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