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Review Medical Reviews

Document ACZONE, 207154, Review Medical Reviews (Orange Book Feb. 24, 2016)
For this 505(b)(1) application, based on the data submitted from the six trials in the clinical development program, safety and efficacy of ACZONE ® (dapsone) Gel, 7.5% have been established for the topical treatment of acne vulgaris in patients 12 years of age and older.
A proposal for the PMR is as follows: Conduct an open-label study to assess safety, pharmacokinetics, and treatment effect of ACZONE® Gel, 7.5% in 100 pediatric subjects age 9 to 11 years 11 Reference ID: 3875816 Clinical Review Patricia C. Brown, MD
Formulations Brand Name Generic Name Owner moderate acne .35 mg Norgestlmate .025 mg/ ethinyl estradiol Orhto-Cyden Orhto Tri- cyclen Jansse" Pharms vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche Compiled by reviewer from website “Drugs at FDA” accessed October 28, 2015 2.3 Availability of Proposed Active Ingredient in the United States ACZONE® (dapsone) Gel, 5% was approved July 7, 2005 (NDA 21794).
The site of Dr. Forsha was issued a Form FDA 483 noting deficiencies including a lack of adherence to the protocol, and inadequate documentation of adverse events (AEs), concomitant medications, informed consent or assent, and drug accountability.
17.6 ± 6.7 186 ± 71 379 ± 142 The clinical pharmacology reviewer explains that: “Relative to Aczone Gel, 5%, daily systemic exposure of dapsone, defined by the geometric mean ratio for maximum plasma concentration (Cmax) and area under the concentration-time curve from time 0 to 24 hours postdose (AUC0-24), was approximately 28.6% and 28.7% lower for formulation 11080X, respectively.
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Letter

Document ACZONE, 207154, Letter (Orange Book Feb. 24, 2016)
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Label

Document ACZONE, 207154, Label (Orange Book Feb. 24, 2016)
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Review OfficerEmployee List

Document ACZONE, 207154, Review OfficerEmployee List (Orange Book Feb. 24, 2016)
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Review Cross Discipline Team Leader Review

Document ACZONE, 207154, Review Cross Discipline Team Leader Review (Orange Book Feb. 24, 2016)
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Review Proprietary Name Reviews

Document ACZONE, 207154, Review Proprietary Name Reviews (Orange Book Feb. 24, 2016)
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Review Approval Letters

Document ACZONE, 207154, Review Approval Letters (Orange Book Feb. 24, 2016)
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Review Clinical Pharmacology Biopharmaceutics Reviews

Document ACZONE, 207154, Review Clinical Pharmacology Biopharmaceutics Reviews (Orange Book Feb. 24, 2016)
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Review Printed Labeling

Document ACZONE, 207154, Review Printed Labeling (Orange Book Feb. 24, 2016)
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Review Chemistry Reviews

Document ACZONE, 207154, Review Chemistry Reviews (Orange Book Feb. 24, 2016)
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Review Summary Review

Document ACZONE, 207154, Review Summary Review (Orange Book Feb. 24, 2016)
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Review Other Reviews

Document ACZONE, 207154, Review Other Reviews (Orange Book Feb. 24, 2016)
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