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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 21083/S-054
`NDA 21110/S-068
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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.,
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`a subsidiary of Pfizer, Inc.
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`Attention: Nhu Debi Tran, Pharm.D.
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`Director, Worldwide Regulatory Strategy
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`PO Box 8299
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`Philadelphia, PA 19101-8299
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`Dear Dr. Tran:
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`Please refer to your Supplemental New Drug Applications (sNDAs) submitted under section
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`505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) as follows:
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` These “Prior Approval” supplemental new drug applications provide for revisions to the carton
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` and container labels for Rapamune as well as for the Amber Oral Syringe included in the
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` Rapamune Oral Solution kit.
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` We have completed our review of these applications. They are approved, effective on the date of
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` this letter, for use as recommended in the agreed-upon labeling text.
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`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and container labels that are identical to the enclosed carton and
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`immediate container labels as soon as they are available, but no more than 30 days after they are
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`printed.
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`Please submit these labels electronically according to the guidance for industry titled “Providing
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`Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications
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`and Related Submissions Using the eCTD Specifications (June 2008).” Alternatively, you may
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`submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or
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` Supplement
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` Number
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` S-068
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` Name of Drug Product
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` Submission date
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` Receipt date
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` Rapamune® (sirolimus) Oral
` Solution, 1 mg/mL
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` Rapamune® (sirolimus)
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` Tablets, 1 mg, 2 mg, and 5 mg
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` March 18, 2013 March 18, 2013
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` March 18, 2013 March 18, 2013
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`NDA
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` 021083
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` 021110
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`Reference ID: 3316582
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` NDA 21083/S-054
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` NDA 21110/S-068
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` Page 2
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` similar material. For administrative purposes, designate this submission “Product
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` Correspondence – Final Printed Carton and Container Labels for approved NDA 21083/S­
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` 054 and NDA 21110/S-068.” 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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` If you have any questions, call Judit Milstein, Chief, Project Management Staff, at 301-796­
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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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` Deputy Director for Safety
` Division of Transplant and Ophthalmology Products
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` Office of Antimicrobial Products
` Center for Drug Evaluation and Research
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`ENCLOSURE: Carton and Container Labels
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`Amber Oral Syringe
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`Reference ID: 3316582
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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/
`----------------------------------------------------
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`OZLEM A BELEN
`05/30/2013
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`Reference ID: 3316582
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