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` NDA 21083/S067
` NDA 21110/S085
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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, PhD
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`Director, Pfizer Global Regulatory Affairs
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`500 Arcola Rd
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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) submitted under
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`section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) as follows:
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` NDA Number Supplement Product Name
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` Date of Submission
` and Receipt
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` September 20, 2019
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` September 20, 2019
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` 21083
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` 21110
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` 067
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` 085
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` Rapamune (sirolimus)
` Oral Solution, 1mg/mL
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` Rapamune (sirolimus)
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` Tablet, 0.5mg, 1mg, 2mg
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` These Prior Approval supplemental new drug applications provide for revisions to the
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` Instructions for Use section of the Package Insert and corresponding revisions to the
` carton labeling, in response to the Supplement Request letter issued on July 30, 2019.
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` APPROVAL & LABELING
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`We have completed our review of these applications. They are approved, effective on
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`the date of this letter, for use as recommended in the enclosed agreed-upon labeling,
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`which is identical to the labeling submitted on September 20, 2019.
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`Reference ID: 4538534
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`

`

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` NDA 21083/S067
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`NDA 21110/S085
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` Page 2
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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 text for the
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`Prescribing Information/Instructions for Use, with the addition of any labeling changes in
`pending “Changes Being Effected” (CBE) supplements, as well as annual reportable
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`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
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`industry SPL Standard for Content of Labeling Technical Qs and As.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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`CARTON AND CONTAINER LABELING
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`Submit final printed carton labeling that is identical to the enclosed carton, as soon as it
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`is available, but no more than 30 days after it is printed. Please submit this labeling
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`electronically according to the guidance for industry Providing Regulatory Submissions
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`in Electronic Format — Certain Human Pharmaceutical Product Applications and
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`Related Submissions Using the eCTD Specifications. For administrative purposes,
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`designate this submission “Final Printed Carton and Container Labeling for
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`approved NDA 21083/S-067.” Approval of this submission by FDA is not required
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`before the labeling is used.
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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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` 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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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4538534
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`

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` NDA 21083/S067
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`NDA 21110/S085
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` Page 3
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` If you have any questions, call Judit Milstein, Chief, Project Management Staff at 301­
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` 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):
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`• Content of Labeling
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`o Prescribing Information
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`o Instructions for Use
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`• Carton Labeling
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4538534
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`

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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/
`------------------------------------------------------------
`
`OZLEM A BELEN
`01/02/2020 02:49:56 PM
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`Reference ID: 4538534
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`