Search Orphan Drug Designations and Approvals
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Generic Name: | Botulinum toxin type A | ||||||||||||||||
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Trade Name: | Botox | ||||||||||||||||
Date Designated: | 03/22/1984 | ||||||||||||||||
Orphan Designation: | Treatment of strabismus and blepharospasms | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | Botulinum toxin type A |
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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 |
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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* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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