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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: 08/12/1998
Orphan Designation: Treatment of spasmodic torticollis (cervical dystonia).
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Ipsen Biopharm Limited
1 Bath Road
Berkshire, SL6 4UH
United Kingdom

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.