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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
Date Designated: 09/15/1992
Orphan Designation: Treatment of synkinetic closure of the eyelid associated with VII cranial nerve aberrant regeneration.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Botulinum Toxin Research Associates, Inc.
1261 Furnace Brook Parkway
Quincy, Massachusetts 02169
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.