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

Feb 25, 2016 · Allergan Announces FDA Approval of ACZONE® (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris ... ACZONE® Gel, 7.5% was approved based on co-primary …

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

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Feb 25, 2016 · Allergan Announces FDA Approval of ACZONE® (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris ... ACZONE® Gel, 7.5% was approved based on co-primary …

prnewswire.com

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FDA Approves Prescription Topical Aczone For Acne - Dermatology …

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Mar 11, 2016 · Allergan announced in late February that the FDA approved its topical Aczone (dapsone) Gel, 7.5% for treatment of acne vulgaris. The newly formulated Aczone 7.5% gel …

dermatologytimes.com

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

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Apr 28, 2015 · dapsone gel, 7.5% group and 6 of 18 in Aczone Gel, 5% group). Aczone Gel, 5% label indicates that systemic exposure is pediatrics 12 – 15 years of age is similar to those 16

fda.gov

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Aczone (dapsone) – New Formulation Approval - OptumRx

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Aczone® (dapsone) – New Formulation Approval • On February 25, 2016, Allergan announced the FDA approval of Aczone (dapsone) 7.5% gel, for the topical treatment of acne vulgaris in …

optumrx.com

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FDA Approves Allergan's Aczone Gel, 7.5% For Acne Vulgaris

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The FDA approved Allergn’s Aczone (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older. Aczone Gel, 7.5% delivers proven …

practicaldermatology.com

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FDA Approves Allergan’s ACZONE® Acne Treatment

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Feb 26, 2016 · Allergan has received approval from the U.S. Food and Drug Administration (FDA) to market ACZONE® (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in …

americanpharmaceuticalreview.com

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FDA Approves Aczone Gel (dapsone) Once A Day To Treat Acne

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Feb 27, 2016 · Allergan plc announced that the Company has received approval from the FDA to market Aczone (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in patients …

medthority.com

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New Topical Gel Approved For Acne Vulgaris - MPR

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Allergan announced that the Food and Drug Administration (FDA) has approved Aczone Gel 7.5%, a new topical treatment for acne vulgaris in patients aged ≥12 years.

empr.com

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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

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

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Feb 26, 2016 · Small Molecules. Allergan Announces FDA Approval of ACZONE® (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris

pipelinereview.eu

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ACZONE NDA 207154 PAC REVIEW 2023 - FINAL

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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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FDA Approves Allergan's Aczone Gel, 7.5% For Acne Vulgaris

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Feb 24, 2016 · The FDA approved Allergn’s Aczone (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older. Aczone G… Newsletter …

practicaldermatology.com

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

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AGN Allergan plc Allergan Announces FDA Approval of ACZONE® (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris ... Allergan Announces FDA Approval of ACZONE® (dapsone) …

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When Will The ACZONE Patents Expire, And When Will ACZONE Go …

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2 days ago · Following FDA approval, ACZONE Gel, 7.5%, was made available nationwide in May 2016. The product was marketed by Allergan plc, a leading global pharmaceutical company, …

drugpatentwatch.com

FAQs about Allergan Announces FDA Approval of ACZONE® (dapsone) Gel, … 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 ...

Is Aczone (dapsone) gel a pregnancy product?

At approval Aczone (dapsone) Gel,5% was categorized as a pregnancy category C product. 2.5 Summary of Presubmission Regulatory Activity Related to Submission 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 ...

Is there a generic version of Aczone?

A generic version of ACZONE was approved as dapsone by NOSTRUM LABS INC on May 6 th, 2016. What excipients (inactive ingredients) are in ACZONE? ...

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 drug?

Aczone is a drug marketed by Allergan and Almirall and is included in two NDAs. There are three patents protecting this drug and one Paragraph IV challenge. This drug has twenty-three patent family members in fifteen countries. The generic ingredient in ACZONE is dapsone. There are eight drug master file entries for this compound. ...