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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 B
Trade Name: Myobloc
Date Designated: 01/16/1992
Orphan Designation: Treatment of cervical dystonia.
Orphan Designation Status: Designated/Approved
Soltice Neurosciences, LLC
4010 Dupont Circle
Suite L-07
Louisville, Kentucky 40207
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Botulinum toxin type B
Trade Name: Myobloc
Marketing Approval Date: 12/08/2000
Approved Labeled Indication: Treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia.
Exclusivity End Date: 12/08/2007 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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