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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Botulinum toxin type A
Trade Name: Dysport
Date Designated: 10/20/1999
Orphan Designation: Treatment of dynamic muscle contractures in pediatric cerebral palsy patients.
Orphan Designation Status: Designated/Approved
Ipsen Biopharmaceuticals, Inc.
650 East Kendall Street
Cambridge, Massachusetts 02142
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Botulinum toxin type A
Trade Name: Dysport
Marketing Approval Date: 07/29/2016
Approved Labeled Indication: Treatment of lower limb spasticity in pediatric patients 2 years of age and older
Exclusivity End Date: 07/29/2023 
Exclusivity Protected Indication* :  Treatment of lower limb spasticity in pediatric cerebral palsy patients 2 years of age and older
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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