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ACZONE

Docket 207154, Orange Book (Feb. 24, 2016)
Case TypeNew Drug Application
Patent9161926
9517219
Orange Book Patent9161926
Orange Book Patent
9517219
Applicant ALMIRALL LLC
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Letter

Document ACZONE, 207154, Letter (Orange Book Sep. 10, 2019)
listed in the February 24, 2016 approval letter and your amendments, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Aczone®
the claimed indication in pediatric patients unless this requirement is waived, deferred, or inapplicable.
To do so, submit the following, in triplicate, (1) a cover letter requesting advisory comments, (2) the proposed materials in draft or mock-up form with
see the draft guidance for industry Providing Regulatory Submissions in Electronic and Non-Electronic Format-Promotional Labeling and Advertising Materials for Human Prescription Drugs.3
If you have any questions, call Strother D. Dixon, Senior Regulatory Project Manager, at
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Label

Document ACZONE, 207154, Label (Orange Book Sep. 10, 2019)
With oral dapsone treatment, folic acid antagonists such as pyrimethamine have been noted to possibly increase the likelihood of hematologic reactions.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
systemic exposure observed in human females as a result of use of the MRHD of ACZONE Gel, 7.5%, based on AUC comparisons.
Use of ACZONE Gel, 7.5% in patients 9 to 11 years of age for this indication is supported by evidence from adequate and well-controlled clinical trials in 1066 subjects 12
No evidence of potential to induce carcinogenicity was observed in a dermal study in which dapsone gel was topically applied to Tg.AC transgenic mice for approximately 26 weeks.
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Label

Document ACZONE, 207154, Label (Orange Book May. 18, 2018)
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Letter

Document ACZONE, 207154, Letter (Orange Book May. 18, 2018)
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Review Pharmacology Reviews

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

Document ACZONE, 207154, Review Statistical Reviews (Orange Book Feb. 24, 2016)
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Review Administrative Documents & Correspondence

Document ACZONE, 207154, Review Administrative Documents & Correspondence (Orange Book Feb. 24, 2016)
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