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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`Food and Drug Administration
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`Silver Spring MD 20993
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` NDA 50797/S-025
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`SUPPLEMENT APPROVAL
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` Pfizer, Inc.
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` Attention: Michele Burtness
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` Senior Manager, Worldwide Safety and Regulatory
` 235 East 42nd Street
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` New York, NY 10017
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`Dear Ms. Burtness:
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`Please refer to your Supplemental New Drug Application (sNDA) dated June 29, 2018, received
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`June 29, 2018, and your amendments, submitted under section 505(b) of the Federal Food, Drug,
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`and Cosmetic Act (FDCA) for the following:
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`NDA 50797/S-025 ZMAX (azithromycin extended release) for Oral Suspension, 2.0g
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`This Prior Approval supplemental new drug application has been submitted in response to
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`the Pregnancy and Lactation Rule (PLLR) published in the Federal Register in December 2014,
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`“Content and Format of Labeling Rule for Human Prescription Drug and Biological Products:
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`Requirements for Pregnancy and Lactation Labeling,” 79 FR 233, December 4, 2014, and 21
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`CFR 201.56(a and d) and 201.57 (c) (9) (I, ii, and iii) updating Section 8 USE IN SPECIFIC
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`POPULATIONS, specifically sub-sections 8.1 Pregnancy and 8.2 Lactation of the
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`Prescribing information (PI). Minor editorial revisions were also made throughout the PI.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
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`text.
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`CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
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`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
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`automated drug registration and listing system (eLIST), as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
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`of labeling must be identical to the enclosed labeling for the package insert, with the addition of
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`any labeling changes in pending “Changes Being Effected” (CBE) supplements, as well as
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`annual reportable changes not included in the enclosed labeling.
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`Reference ID: 4423479
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`NDA 50797/S-025
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`Page 2
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` Information on submitting SPL files using eList may be found in the guidance for industry titled
` “SPL Standard for Content of Labeling Technical Qs and As” at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
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` Also within 14 days, amend all pending supplemental applications that include labeling changes
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` for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
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` with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word format, that includes the
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` changes approved in this supplemental application, as well as annual reportable changes. To
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` facilitate review of your submission(s), provide a highlighted or marked-up copy that shows all
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` changes, as well as a clean Microsoft Word version. The marked-up copy should provide
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` appropriate annotations, including supplement number(s) and annual report date(s).
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` REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Jacquelyn Rosenberger, PharmD, Regulatory Project Manager, at
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`(301) 796-9179.
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`Sincerely,
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`{See appended electronic signature page}
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`Dmitri Iarikov, MD, PhD
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`Deputy Director
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`Division of Anti-Infective Products
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`Office of Antimicrobial Products
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`Center for Drug Evaluation and Research
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`ENCLOSURE:
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`Content of Labeling
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`Reference ID: 4423479
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`Signature Page 1 of 1
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`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
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`/s/
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`DMITRI IARIKOV
`04/24/2019 12:44:20 PM
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`Reference ID: 4423479
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