Aczone (dapsone) FDA Approval History - Drugs.com

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

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Food and Drug Administration ... 2.1.1 Regulatory History ... ACZONE ® (dapsone) gel, 5% was approved on July 7, 2005 for the indication of topical treatment of acne vulgaris. ...

fda.gov

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Aczone: Package Insert / Prescribing Info - Drugs.com

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Apr 30, 2024 · 11. Aczone Description. ACZONE (dapsone) Gel, 7.5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. ... Approval History Drug history …

drugs.com

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Department Of Health And Human Services Public Health …

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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

fda.gov

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Once-Daily Aczone Approved To Treat Acne - Pharmacy Times

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Feb 29, 2016 · Allergan has received the FDA’s permission to market dapsone (Aczone) gel, 7.5%, to patients aged 12 years and older with both inflammatory and non-inflammatory acne. …

pharmacytimes.com

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Aczone (dapsone) – New Formulation Approval - OptumRx

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• On February 25, 2016, Allergan announced the FDA approval of Aczone (dapsone) 7.5% gel, for the topical treatment of acne vulgaris in patients 12 years of age and older. — Aczone is also …

optumrx.com

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

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Aczone® (dapsone) gel, 7.5% was approved in 2016 for a treatment of acne vulgaris in patients 12 years of age and older. The original approval had a postmarketing requirement (PMR 3017 …

fda.gov

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FDA Approves Prescription Acne Treatment - Pharmacy Times

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Feb 29, 2016 · The FDA has approved Aczone (dapsone) Gel, 7.5%, a new prescription topical treatment for acne patients 12 years and older. Aczone is made by Allergan plc. A once-a-day …

pharmacytimes.com

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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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7.1 Trimethoprim-Sulfamethoxazole - Food And Drug …

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ACZONE Gel, 5%, gently and completely. ACZONE Gel, 5%, is gritty with visible drug substance particles. Wash hands after application of ACZONE Gel, 5%. If there is no improvement after …

fda.gov

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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

fda.gov

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

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Apr 28, 2015 · Dapsone is the same drug substance contained in Aczone (dapsone) Gel, 5% (NDA 21794), which is currently approved for twice daily application for the topical treatment of …

fda.gov

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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

fda.gov

FAQs about Aczone (dapsone) FDA Approval History - Drugs.com Coupon?

Is Aczone approved by the FDA?

Aczone is a brand name of dapsone topical, approved by the FDA in the following formulation (s): Has a generic version of Aczone been approved? A generic version of Aczone has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. ...

What is Aczone (dapsone) gel?

ACZONE (dapsone) Gel, 7.5%, contains dapsone, a sulfone, in an aqueous gel base for topical dermatologic use. ACZONE Gel, 7.5% is an off-white to yellow gel with suspended particles. Chemically, dapsone has an empirical formula of C 12 H 12 N 2 O 2 S. ...

What is Aczone (dapsone) used for?

Aczone (dapsone) is a sulfone indicated for the topical treatment of acne vulgaris. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. ...

Is Aczone a brand name?

Last updated on Nov 6, 2024. Aczone is a brand name of dapsone topical, approved by the FDA in the following formulation (s): Has a generic version of Aczone been approved? A generic version of Aczone has been approved by the FDA. ...

Is there a generic version of Aczone?

A generic version of Aczone has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Aczone and have been approved by the FDA: ...

What is Aczone used for?

Aczone is an anti-infective medication. Aczone is a topical gel used to help treat acne. The mechanism of action of in treating acne is not known. It is not for oral use. Use is contraindicated in persons with a hypersensitivity to dapsone. Aczone gel may also be used for purposes not listed in this medication guide. ...