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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 (Text),
(PDF)
Labeling (PDF)
Statistical Review (PDF)
Supplemental Clinical Review (PDF)
Chemistry, Manufacturing, and Controls Section Review (PDF)
Clinical Review (PDF)
Last Updated: 7/23/2001
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Date created: September 16, 2003 |
