`
` NDA 21083/S064
`
` NDA 21110/S083
`
`
`
`SUPPLEMENT APPROVAL
`
`
`
`
`
`
` NDA Number Supplement Product Name
`
`
`
`
`
`
` PF Prism C.V.
`
`
` Attention: Deneen Stewart, PhD
`
`
` Director, Worldwide Safety and Regulatory
`
`
` 500 Arcola Road
` Collegeville, PA 19426
`
`
`
`
`
`
`Dear Dr. Stewart:
`
`
`
`
`Please refer to your supplemental new drug applications (sNDAs) submitted under
`
`
`
`section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) as follows:
`
`
`Date of Submission
`
` and Receipt
` June 25, 2018
`
`
`
`
`
`
`
` June 25, 2018
`
`
`
` 21083
`
`
`
` 21110
`
`
`
` 064
`
`
`
` 083
`
`
`
`
`
` Rapamune (sirolimus) Oral
`
` Solution, 1mg/mL
` Rapamune (sirolimus) Tablet,
`
` 0.5mg, 1mg, 2mg
`
`
`
`These Prior Approval supplemental new drug applications provides for revisions to the
`
`
`
`
`package insert to comply with the Pregnancy and Lactation Labeling Rule (PLLR)
`
`
`format.
`
`
`APPROVAL & LABELING
`
`
`
`
`
`
`
`We have completed our review of these applications, as amended. They are approved,
`
`
`effective on the date of this letter, for use as recommended in the enclosed agreed-
`
`upon labeling, which is identical to the labeling submitted on June 21, 2019.
`
`
`CONTENT OF LABELING
`
`
`
`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
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling text for the
`
`
`
`
`Prescribing Information, Instructions for Use and Medication Guide, with the addition of
`
`
`
`
`
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`
`
`
`Reference ID: 4462151
`
`

`

`
`
`
`
` NDA 21083/S064
`
` NDA 21110/S083
`
` Page 2
`
`
` any labeling changes in pending “Changes Being Effected” (CBE) supplements, as well
`
`
` as annual reportable changes not included in the enclosed labeling.
`
`
`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 The SPL will be
`
`
`
`
`accessible from publicly available labeling repositories.
`
`
`
`
`
`Also, within 14 days, amend all pending supplemental applications that include labeling
`
`
`
`
`
`
`changes for these NDAs, 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 Microsoft Word
`
`format, that includes the changes approved in these supplemental applications, as well
`as annual reportable changes. To facilitate review of your submission(s), 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).
`
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for approved NDAs
`
`
`
`
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`If you have any questions, call Judit Milstein, Chief, Project Management Staff at 301­
`
`
`
`
`796-0763.
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`
`Ozlem Belen, MD, MPH
`
`Acting Director
`
`Division of Transplant and Ophthalmology Products
`
`Office of Antimicrobial Products
`
`Center for Drug Evaluation and Research
`
`
`
`
`ENCLOSURE(S): Content of Labeling
`
`
`
`• Prescribing Information
`
`
`• Medication Guide
`
`
`Instructions for Use
`
`
`
`•
`
`
`
`
` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`
`
`
`
`U.S. Food and Drug Administration
`
`Silver Spring, MD 20993
`
`www.fda.gov
`
`
`
`
`
`Reference ID: 4462151
`
`

`

`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
`07/15/2019 05:15:42 PM
`
`Reference ID: 4462151
`
`(
`
`
`
`