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` NDA 21083/S066
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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, Global Regulatory Affairs
` 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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`May 2, 2019, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
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`Act (FDCA) for Rapamune (sirolimus) oral solution, 1 mg/mL.
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`This Prior Approval supplemental new drug application provides for revisions to the
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`carton label to harmonize the contents with the text of the Instructions for Use section of
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`the product labeling approved on April 5, 2019.
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`APPROVAL & LABELING
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`We have completed our review of this application. It is approved, effective on the date of
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`this letter, for use as recommended in the enclosed agreed-upon carton label.
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`CARTON LABELING
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`Submit final printed carton label that is identical to the enclosed carton labeling, as soon
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`as it 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 Labeling for approved
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`NDA 21083/S066.” Approval of this submission by FDA is not required before the
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`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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`Reference ID: 4450198
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` NDA 21083/S066
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` Page 2
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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
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`Products
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`Office of Antimicrobial Products
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`Center for Drug Evaluation and Research
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`ENCLOSURE: 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: 4450198
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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
`06/18/2019 01:57:41 PM
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`Reference ID: 4450198
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`(
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