CLINICAL REVIEW - U.S. Food and Drug Administration

Clinical Review Amy Sakulich Woitach, D.O., M.S. NDA 207154 S-004 Aczone (dapsone) gel, 7.5% CDER Clinical Review Template 1 Version date: September 6, 2017 for all NDAs and BLAs

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CLINICAL REVIEW - U.S. Food And Drug Administration

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Clinical Review Amy Sakulich Woitach, D.O., M.S. NDA 207154 S-004 Aczone (dapsone) gel, 7.5% CDER Clinical Review Template 1 Version date: September 6, 2017 for all NDAs and BLAs

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ACZONE NDA 207154 PAC REVIEW 2023 - FINAL - U.S. Food …

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Aczone (dapsone) gel, 7.5% is a sulfone that was initially approved in the United States on February 24, 2016. Aczone gel, 7.5% is currently indicated for the topical treatment of acne

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Office Of Clinical Pharmacology Review - U.S. Food And Drug …

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3 4. INDIVIDUAL STUDY REVIEW . Study 1679-401-006 Title: An open-label Phase 4 safety and efficacy trial of ACZONE® (Dapsone) Gel, 7.5% in 9 to 11 years-old subjects with acne …

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CENTER FOR DRUG EVALUATION AND RESEARCH - Food And …

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amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for ACZONE (dapsone) Gel, 7.5%. This new drug application provides for the use of …

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Aczone Gel 7.5% Approved To Treat Acne In Younger Patients

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Sep 16, 2019 · The approval of Aczone Gel 7.5% in patients 9 to 11 years of age was supported by evidence from adequate and well-controlled clinical trials in 1066 patients 12 years of age …

dermatologyadvisor.com

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Allergan Announces FDA Approval Of ACZONE® (dapsone) Gel, …

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Feb 25, 2016 · "ACZONE® Gel, 7.5%, is a new once-daily option that was shown to have significant improvement in patients' acne after 12 weeks of use," said Linda Stein Gold, MD, …

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Office Of Clinical Pharmacology Review (Aczone) - U.S. Food …

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Apr 28, 2015 · OFFICE OF CLINICAL PHARMACOLOGY REVIEW NDA: 207154 Submission Date(s): 4/28/2015 Brand Name Aczone Gel, 7.5% Generic Name Dapsone Primary Reviewer …

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207154Orig1s000 - Food And Drug Administration

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Dapsone is a synthetic sulfone with antimicrobial and anti-inflammatory properties. Dapsone is the same drug substance contained in Aczone (dapsone) Gel, 5% (NDA 21794), which is currently …

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STATISTICAL REVIEW AND E VALUATION - U.S. Food And …

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On August 28, 2013, the Agency and the applicant met for an End-of-Phase 2 (EOP2) meeting to discuss the development plan for ACZONE (dapsone) gel, 7.5%.

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Department Of Health And Human Services Public Health …

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The FDA approved Aczone (dapsone) gel, 7.5% (NDA 207154) on February 24, 2016 for the topical treatment of acne vulgaris in patients 12 years of age and older. This review was

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FAQs about CLINICAL REVIEW - U.S. Food and Drug Administration Coupon?

Should Aczone (dapsone) gel be approved?

1.1 Recommendation on Regulatory Action This reviewer recommends an approval action for the current NDA 207154, ACZONE (dapsone) Gel, 7.5% for the topical treatment of acne vulgaris in patients 12 years of age and older. 1.2 Risk Benefit Assessment The applicant, Allergan, Inc., has submitted a 505(b)1 New Drug Application for ACZONE ...

What is the clinical development program for Aczone (dapsone) gel?

The clinical development program for Aczone 7.5% gel was conducted under IND 054440. An End of Phase 2 meeting was held August 28, 2013. Key discussion points included the following: 16 Reference ID: 3875816 Clinical Review Patricia C. Brown, MD NDA 207154 ACZONE (dapsone) Gel, 7.5% will be forthcoming from the Agency. ...

Are there clinical microbiology studies performed during the Aczone 7.5 % gel development program?

No clinical microbiology studies were performed during the Aczone 7.5 % gel development program. 4.3 Preclinical Pharmacology/Toxicology Please see Pharmacology/Toxicology Review (dated 11/12/2015) by Norman A. See, PhD. ...

How much Aczone is used a day?

Subjects applied study product once daily for 12 weeks. The median total dose used was41.43 grams in the Aczone 7.5% gel group and 42.27 grams in the vehicle group. The pooled safety database includes 4336 subjects exposed to study drugs; 2161 to Aczone 7.5% gel and 2175 to vehicle. Subjects ranged in age from 12 to 63 years. ...

How much Aczone gel was used?

The mean total amount of study medication used was50.34 grams in the ACZONE Gel, 7.5% group and 51.57 grams in the vehicle group. Table 22: Total Amount of Study Drug Used (Pooled Safety Trials) Exposure ACZONE Gel, 7.5% a Vehicle a N = 2107 N = 2134 Mean 50.34 51.57 SD 39.359 38.682 Median 41.43 42.27 Minimum 0 0 Maximum ...

Does Aczone gel affect plasma concentrations?

It is further noted that, trial 225678-004 (PK, 4-arm, active controlled) demonstrated that mean plasma concentrations of dapsone (including mean peak and trough concentrations) following application of ACZONE Gel, 7.5% once-daily wereconsistently lower than those following application of ACZONE Gel, 5% twice-daily. 87 Reference ID: 3875816 ...