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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

DateArticle
Jun 16, 2017Approval Ipsen Announces FDA approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults
Aug  1, 2016Approval 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, 2015Approval Ipsen Announces FDA Approval of Dysport (abobotulinumtoxinA) for Upper Limb Spasticity
Apr 30, 2009Approval FDA Approves Dysport (abobotulinumtoxinA) for Cervical Dystonia and Glabellar Lines
Dec 29, 2008FDA Issues Complete Response Letter to Ipsen for Dysport Biologics License Application
May 19, 2008Ipsen and Medicis Announce Acceptance of Reloxin BLA in Aesthetics by FDA
Mar 17, 2008Ipsen and Medicis Announce Submission of Reloxin BLA in Aesthetics to the FDA
Jan 31, 2008Ipsen: FDA Accepts for Filing a Biologics License Application (BLA) for Dysport in Cervical Dystonia
Dec  6, 2007Ipsen and Medicis Announce Submission of Reloxin in Aesthetics to the FDA
Dec  6, 2007Ipsen Submits a Biologics License Application in Cervical Dystonia to the FDA for Dysport

Further information

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