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U.S. Department of Health and Human Services

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Botulinum Toxin Type B Product Approval Information - Licensing Action

Proper name: Botulinum Toxin Type B
Tradename: MYOBLOC
Manufacturer: Elan Pharmaceuticals, South San Francisco, CA, License #1579
Indication for Use: Treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain
Approval Date: 12/08/2000
Type of submission: Biologics license application

 


Approval Letter (PDF)

Labeling (PDF)

Statistical Review (PDF)

Supplemental Clinical Review (PDF)

Chemistry, Manufacturing, and Controls Section Review (PDF)

Clinical Review (PDF)