`
`
`
`DEPARTMENT OF HEALTH AND HUMAN SERVICES
`
`
`
`
`
`
`
`
`NDA 021083/S-055
`
`NDA 021110/S-073
`
`
`
`
`
`
` Food and Drug Administration
`
`
`
` Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`
`
`PF PRISM C.V.
`
`
`c/o Pfizer, Inc.
`
`500 Arcola Road
`
`Collegeville, PA 19426
`
`Attention:
`
`
`
`
`
`Deneen Stewart, PhD
`
`
`
`Director, Worldwide Safety and Regulatory
`
`
`
`
`Dear Dr. Stewart:
`
`
`
`
`
`
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated December 23, 2014,
`
`received December 23, 2014, submitted under section 505(b) of the Federal Food, Drug, and
`
`Cosmetic Act (FDCA) for the following:
`
`
`
`
`
`
`NDA#
`
`
`021083
`
`
`
`
`
`
`
`
`Supplement# Product Description
`
`
`
`
`
`
`S-055
`
`
`Rapamune (sirolimus) Oral Solution, 1 mg/mL
`
`
`
`
`
`
`021110
`
`
`
`
`
`S-073
`
`
`
`
`
`Rapamune (sirolimus) Tablets, 0.5 mg, 1 mg, and 2 mg
`
`
`
`
`We acknowledge receipt of your amendments dated February 12, and May 22, 26, and 28, 2015.
`
`
`
`
`
`
`These Prior Approval supplemental new drug applications provide for the addition of a new
`
`
`
`
`
`indication for the treatment of patients with lymphangioleiomyomatosis (LAM).
`
`
`
`APPROVAL & LABELING
`
`
`We have completed our review of these supplemental applications, as amended. It is approved,
`
`
`
`
`
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`
`
`text.
`
`
`
`
`
`
`
`Reference ID: 3768008
`
`

`

`
`
`
`
`
`
`
`
`
` NDA 021083/S-055
`
` NDA 021110/S-073
`
` Page 2
`
`
` WAIVER OF HIGHLIGHTS SECTION
`
` We are waiving the requirements of 21 CFR 201.57(d)(8) regarding the length of Highlights of
`
`
`prescribing information. This waiver applies to all future supplements containing revised
`labeling unless we notify you otherwise.
`
`
`
` 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
`
`
` http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`
`of labeling must be identical to the enclosed labeling (text for the package insert, text for
`
`
`
`
`Medication Guide, text for instructions for use), with the addition of 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 titled
`
`
`
`“SPL Standard for Content of Labeling Technical Qs and As at
`
`
`
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf
`
`
`The SPL will be accessible from publicly available labeling repositories.
`
`
`
`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`
`
`
`for this NDA, 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 MS Word format, that includes the
`
`
`
`
`
`changes approved in this supplemental application, as well as annual 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 Microsoft Word version. The marked-up copy
`
`should provide appropriate annotations, including supplement number(s) and annual report
`
`
`
`
`
`
`
`date(s).
`
`
`REQUIRED PEDIATRIC ASSESSMENTS
`
`
`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`
`
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`
`
`
`administration are required to contain an assessment of the safety and effectiveness of the
`
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`
`
`deferred, or inapplicable.
`
`
`Because this drug product for this indication has an orphan drug designation, you are exempt
`
`
`from this requirement.
`
`
`
`
`
`
`Reference ID: 3768008
`
`

`

`
` NDA 021083/S-055
`
` NDA 021110/S-073
`
` Page 3
`
`
` PROMOTIONAL MATERIALS
`
` You may request advisory comments on proposed introductory advertising and promotional
`
`
`
`
`
`
` labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
`
`
`
`
`
`
`
`Food and Drug Administration
`
` Center for Drug Evaluation and Research
`
` Office of Prescription Drug Promotion (OPDP)
`
`
` 5901-B Ammendale Road
` Beltsville, MD 20705-1266
`
`
`
`
`
`You must submit final promotional materials and package insert(s), accompanied by a Form
`
`
`
`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
`
`FDA 2253 is available at
`
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`
`
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`
`more information about submission of promotional materials to the Office of Prescription Drug
`
`
`
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
`
`
`REPORTING REQUIREMENTS
`
`
`
`
`
`We remind you that you must comply with reporting requirements for an approved NDA
`
`
`(21 CFR 314.80 and 314.81).
`
`
`
`
`
`
`If you have any questions, call Nina Ton, Regulatory Project Manager, at (301) 796-1648.
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Lydia Gilbert-McClain, MD
`
`Deputy Director
`
`Division of Pulmonary, Allergy, and Rheumatology Products
`
`
`Office of Drug Evaluation II
`
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURE:
`
`
`Content of Labeling
`
`
`
`Reference ID: 3768008
`
`

`

`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`LYDIA I GILBERT MCCLAIN
`05/28/2015
`
`Reference ID: 3768008
`
`