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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 21083/S-053
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`NDA 21110/S-067
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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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`
`Wyeth Pharmaceuticals, Inc.
`a subsidiary of Pfizer, Inc.
`Attention: Nhu M. Tran, PharmD
` Director, WRS
`P. O. Box 8299
`Philadelphia, PA 19101-8299
`
`
`Dear Dr. Tran:
`Please refer to your Supplemental New Drug Applications (sNDAs) dated and received
`September 24, 2012, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic
`Act (FDCA) for Rapamune (sirolimus), Oral Solution, 1 mg/mL (NDA 21083) and Rapamune
`(sirolimus), Tablets, 1 mg, 2mg, and 5 mg (NDA 21110).
`
`We acknowledge receipt of your amendments dated March 4, 2013.
`
`These “Changes Being Effected” supplemental new drug applications provide for the following
`revisions to the package insert (additions are noted as underlined text).
`
`
`6 ADVERSE REACTIONS
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`6.1 Clinical Studies Experience in Prophylaxis of Organ Rejection Following Renal
`Transplantation
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` … The following adverse reactions were reported less frequently (≥ 3%, but < 20%
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` Urogenital System – Pyelonephritis, decline in renal function (creatinine increas)ed)
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` in long-term combination of cyclosporine with Rapamune [see Warnings and
`Precautions (5.8)], ovarian cysts, menstrual disorders (including amenorrhea and
`menorrhagia).
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`6.6 Postmarketing Experience
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`…
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` Urogenital – Nephrotic syndrome, proteinuria, focal segmental glomerulosclerosis,
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`ovarian cysts, menstrual disorders (including amenorrhea and menorrhagia).
`Azoospermia has been reported with the use of Rapamune and has been reversible
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`upon discontinuation of Rapamune in most cases.
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`Reference ID: 3272763
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` NDA 21083/S-053
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` NDA 21100/S-067
`Page 2
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`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 agreed-upon labeling text, submitted as
`Final Printed Labeling on March 4, 2013.
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`DRUG REGISTRATION AND LISTING
`
`
`All drug establishment registration and drug listing information is to be submitted to FDA
`electronically, via the FDA automated system for processing structured product labeling (SPL)
`files (eLIST). At the time that you submit your final printed labeling (FPL), the content of
`labeling (Drug Facts) should be submitted in SPL format as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
`Information on submitting SPL files using eLIST may be found in the guidance for industry
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`titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf. In addition, representative container or carton labeling, whichever includes
`Drug Facts, (where differences exist only in the quantity of contents statement) should be
`submitted as a JPG file.
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`REPORTING REQUIREMENTS
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`
`We remind you that you must comply with reporting requirements for approved NDAs (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.
`Sincerely,
`
`{See appended electronic signature page}
`
`
`
`Ozlem Belen, MD, MPH
`Deputy Director for Safety
`Division of Transplant and Ophthalmology Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
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`ENCLOSURE: Package Insert
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`Reference ID: 3272763
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`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`OZLEM A BELEN
`03/07/2013
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`Reference ID: 3272763
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`
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