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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: 03/22/1984
Orphan Designation: Treatment of strabismus and blepharospasms
Orphan Designation Status: Designated/Approved
Allergan, Inc.
2525 Dupont Drive
P.O. Box 19534
Irvine, California 92713
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: Botox
Marketing Approval Date: 12/29/1989
Approved Labeled Indication: Treatment of strabismus associated with dystonia in adults (patients 12 years of age and above)
Exclusivity End Date: 12/29/1996 
Exclusivity Protected Indication* :  
2 Generic Name: Botulinum toxin type A
Trade Name: Botox
Marketing Approval Date: 12/30/1989
Approved Labeled Indication: Treatment of blepharospasm associated with dystonia in adults (patients 12 years of age and above)
Exclusivity End Date: 12/30/1996 
Exclusivity Protected Indication* :  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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