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` NDA 021821/S-048
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` SUPPLEMENT APPROVAL
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` PF Prism CV
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` c/o Pfizer Inc.
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` Attention: Tricia Racanelli, PharmD
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` Director, Pfizer Heath Global Regulatory Affairs Branch
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` 235 East 42nd Street
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` New York, NY 10017-5755
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` Dear Dr. Racanelli:
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` Please refer to your supplemental new drug application (sNDA) dated June 17, 2019,
` received June 17, 2019, submitted under section 505(b) of the Federal Food, Drug, and
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` Cosmetic Act (FDCA) for Tygacil (tigecycline) for Injection.
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` This Prior Approval supplemental new drug application has been submitted to comply
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` with Pregnancy and Lactation Labeling Rule (PLLR) published in the Federal Register
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` on December 4, 2014 and the Agency letter dated December 5, 2018.
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` APPROVAL & LABELING
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` We have completed our review of this application, as amended. It is approved, effective
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` on the date of this letter, for use as recommended in the enclosed agreed-upon
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` labeling.
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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
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` content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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` the FDA automated drug registration and listing system (eLIST), as described at
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` FDA.gov.1 Content of labeling must be identical to the enclosed labeling (Prescribing
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` Information), with the addition of any labeling changes in pending “Changes Being
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` Effected” (CBE) supplements, as well as annual reportable changes not included in the
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` enclosed labeling.
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` Information on submitting SPL files using eList may be found in the guidance for
` industry SPL Standard for Content of Labeling Technical Qs and As.2
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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`Reference ID: 4547456
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` NDA 021821/S-048
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` Page 2
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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
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` changes for this NDA, including CBE supplements for which FDA has not yet issued an
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` action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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` format, that includes the changes approved in this supplemental application, as well as
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` annual reportable changes. To facilitate review of your submission(s), provide a
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` highlighted or marked-up copy that shows all changes, as well as a clean Microsoft
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` Word version. The marked-up copy should provide appropriate annotations, including
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` 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 Christopher L. Smith, PharmD, MPH, Regulatory Project
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` Manager at (301) 796-4851.
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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-Infectives
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` Office of Infectious Diseases
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` Center for Drug Evaluation and Research
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` ENCLOSURE(S):
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`• Content of Labeling
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`o Prescribing Information
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` U.S. Food and Drug Administration
` Silver Spring, MD 20993
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` www.fda.gov
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`Reference ID: 4547456
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`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`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.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
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`DMITRI IARIKOV
`01/16/2020 12:42:31 PM
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`Reference ID: 4547456
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