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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21083/S065
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` NDA 21110/S084
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`PF PRISM, C.V.
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`c/o Pfizer, Inc.
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`Attention: Deneen Stewart
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`Director, Worldwide Safety and Regulatory
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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 Applications (sNDAs), dated and received on
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`October 5, 2018, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
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`Act (FDCA or the Act) for the following:
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`NDA Number
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`Supplement Product Name
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` Rapamune (sirolimus) Oral Solution, 1mg/mL
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`21083
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`21110
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`065
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`084
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` Rapamune (sirolimus) Tablet, 0.5mg, 1mg, 2mg
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` These Prior Approval supplemental applications propose revisions to the Instructions for
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` Use section of the Package Insert.
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` APPROVAL & LABELING
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` We have completed our review of these supplemental applications, as amended. They are
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`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
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`upon labeling text which is identical to the labeling text submitted on April 3, 2019.
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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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`Reference ID: 4415418
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` NDA 21083/S065
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` NDA 21110/S084
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` Page 2
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` of labeling must be identical to the enclosed labeling text for the Prescribing Information,
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` Instructions for Use, and Medication Guide, with the addition of any labeling changes in pending
` “Changes Being Effected” (CBE) supplements, as well as annual reportable changes not
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` 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
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`“SPL Standard for Content of Labeling Technical Qs and As” at
`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 Judit Milstein, Chief, Project Management Staff at 301-796-0763.
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`Sincerely,
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`{See appended electronic signature page}
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`Ozlem Belen, MD, MPH
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`Acting Director
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`Division of Transplant and Ophthalmology Products
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`Office of Antimicrobial Products
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`Center for Drug Evaluation and Research
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`ENCLOSURE(S): Content of Labeling
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`Reference ID: 4415418
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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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`OZLEM A BELEN
`04/05/2019 03:21:19 PM
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`Reference ID: 4415418
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