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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.