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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

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