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)