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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21-821/S-045
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`PF Prism CV
`c/o Pfizer Inc.
`Attention: Nadia Kirzecky
`Director, Pfizer Heath Global Regulatory Affairs Branch
`235 East 42nd Street
`New York, NY 10017
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`Dear Ms. Kirzecky:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated October 17, 2017,
`received October 17, 2017, and your amendments, submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for Tygacil (tigecycline) for Injection.
`
`This Prior Approval supplemental new drug application provides for updates to the
`REFERENCE section (15) and CLINICAL PHARMACOLOGY Microbiology subsection
`(12.4).
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`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
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling text for the package insert with the addition
`of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as well as
`annual reportable changes not included in the enclosed labeling.
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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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`Reference ID: 4249222
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`NDA 21-821/S-045
`Page 2
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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
`for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
`with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
`changes approved in this supplemental application, as well as annual reportable changes and
`annotate each change. To facilitate review of your submission, provide a highlighted or marked-
`up copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
`should provide 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
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Carmen DeBellas, Regulatory Project Manager, at (301) 796-
`1203.
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`Sincerely,
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`{See appended electronic signature page}
`
`Dmitri Iarikov, MD, PhD
`Deputy Director (acting)
`Division of Anti-Infective Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
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`Reference ID: 4249222
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`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`DMITRI IARIKOV
`04/16/2018
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`Reference ID: 4249222
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`(
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