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`A D M I N I STRATION
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` NDA 021110/S-086
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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: Deneen Stewart, PhD
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`Director, Pfizer Global Regulatory Affairs
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`500 Arcola Road
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`Collegeville, PA 19426
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`Dear Dr. Stewart:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received
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`February 11, 2021, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Rapamune (sirolimus) tablet.
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`This Prior Approval supplemental new drug application provides for updates to the
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`“United States Prescribing Information” (USPI) and “Instructions for Use” documents for
`Rapamune (sirolimus) Tablets because of changes recently made to these shared
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`documents for Rapamune (sirolimus) Oral Solution as per the referenced NDA 21-083.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed agreed-
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`upon 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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
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`Content of labeling must be identical to the enclosed labeling (text for the prescribing
`information) with the addition of any labeling changes in pending “Changes Being
`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
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`industry titled SPL Standard for Content of Labeling Technical Qs and As at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guida
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`nces/UCM072392.pdf.
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`The SPL will be accessible via publicly available labeling repositories.
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` U.S. Food & Drug Administration
` Silver Spring, MD 20993
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` www.fda.gov
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`

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`Sincerely,
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`{See appended electronic signature page}
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`
`Gurpreet Gill-Sangha, Ph.D.
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`Branch Chief, B3
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`Division of Post-Marketing Activities I
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`Office of Lifecycle Drug Products
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`Office of Pharmaceutical Quality
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`Center for Drug Evaluation and Research
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` NDA 021110/S-086
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` Page 2
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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 MS Word format,
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` that includes the changes approved in this supplemental application, as well as annual
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` 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
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` 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
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Teicher Agosto, Regulatory Business Process Manager,
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`at (240) 402 - 3777.
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`Enclosure(s):
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`Content of Labeling
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` U.S. Food & Drug Administration
` Silver Spring, MD 20993
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` www.fda.gov
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`

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`Gurpreet
`Gill Sangha
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`Digitally signed by Gurpreet Gill Sangha
`Date: 8/09/2021 08:34:32AM
`GUID: 5135f2ad000117842392c50c36c7f28a
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