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CENTER FOR DRUG EVALUATION AND RESEARCH
Approval Package for:
APPLICATION NUMBER:
BLA 103000-S5232
Trade Name:
Botox
Generic Name:
onabotulinumtoxinA
Sponsor:
Allergan Inc.
Approval Date:
August 24th 2011
Indications: Treatment of urinary incontinence due to detrusor overactivity associated with neurological condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER: BLA 103000-5232
CONTENTS
Reviews / Information Included in this NDA Review. Approval Letter Approvable Letter Labeling Summary Review Officer/Employee List Office Director Memo Cross Discipline Team Leader Review Medical Review(s) X Chemistry Review(s) Environmental Assessment Pharmacology Review(s) Statistical Review(s) Microbiology Review(s) Clinical Pharmacology/Biopharmaceutics Review(s) X Risk Assessment and Risk Mitigation Review(s) Proprietary Name Review(s) Other Review(s) Administrative/Correspondence Document(s)
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER: BLA 103000-5232
MEDICAL REVIEW(S)
CENTER FOR DRUG EVALUATION AND RESEARCH
APPLICATION NUMBER: BLA 103000-5232
PHARMACOLOGY REVIEW(S)
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