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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:  Botox
Date Designated:  12/06/1991
Orphan Designation:  Treatment of dynamic muscle contracture in pediatric cerebral palsy patients
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  06/20/2019 
Approved Labeled Indication:  BOTOX is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age.
Exclusivity End Date:    06/20/2026 
Exclusivity Protected Indication* :  For the treatment of upper limb spasticity in pediatric cerebral palsy patients 2 to 17 years of age
Allergan, Inc.
2525 Dupont Drive
T1-2A
Irvine, California 92623
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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