`
`DEPARTMENT OF HEALTH & HUMAN
`SERVICES
`
`
`
`
`NDA 021083/S-050
`NDA 021110/S-060
`
`Public Health Service
`
`
`
` Food and Drug Administration
`Rockville, MD 20857
`
`SUPPLEMENTS APPROVAL
`RELEASE REMS REQUIREMENT
`
`
`Wyeth Pharmaceuticals, Inc.
`Attention: Ms. Sharon Pfleger, M.S.
`Manager, Worldwide Regulatory Strategy
`P.O. Box 8299
`Philadelphia, PA 19101-8299
`
`Dear Ms. Pfleger:
`
`Please refer to your supplemental new drug applications, dated and received on May 11, 2011,
`and submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Rapamune®
`
`(sirolimus) Oral Solution, 1mg/mL (NDA 21-083), and Rapamune® (sirolimus) Tablets, 1 mg,
`2 mg, and 5 mg (NDA 21-110).
`
`We acknowledge receipt of your risk evaluation and mitigation strategy (REMS) assessment
`
`dated May 26, 2011.
`
`These supplemental new drug applications propose elimination of the requirement for the
`approved Rapamune® (sirolimus) Oral Solution and Tablets REMS.
`
`We have completed our review of these supplemental applications. They are approved, effective
`
`on the date of this letter.
`
`
`RISK EVALUATION AND MITIGATION STRATEGY REQUIREMENTS
`
`The REMS for Rapamune® (sirolimus) Oral Solution and Tablets was originally approved on
`November 23, 2010. The REMS consists of a Medication Guide and a timetable for submission
`
`of assessments of the REMS.
`
`You propose that FDA no longer require a REMS for Rapamune® (sirolimus).
`
`We have determined that maintaining the Medication Guide as part of the approved labeling is
`adequate to address the serious and significant public health concern and meets the standard in
`21 CFR 208.1. Therefore, it is no longer necessary to include the Medication Guide as an
`element of the approved REMS to ensure that the benefits of Rapamune® (sirolimus) outweigh
`its risks, and a REMS for Rapamune® (sirolimus) is no longer required.
`.
`
`
`
`Reference ID: 2956531
`
`
`
`
` NDA 21-082/S-050
`
` NDA 21-110/S-060
`Page 2
`
`
`We remind you that the Medication Guide will continue to be part of the approved labeling in
`accordance with 21 CFR 208.
`
` 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 Hyun Son, Pharm.D., Regulatory Project Manager, at
`(301) 796-1600.
`
`
`
`
`Sincerely,
`
`
`{See appended electronic signature page}
`
`Ozlem Belen, M.D., MPH
`Division Director for Safety
`Division of Transplant and Ophthalmic Products
`Office of Antimicrobial Products
`Center for Drug Evaluation and Research
`
`Reference ID: 2956531
`
`
`
`---------------------------------------------------------------------------------------------------------
`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
`06/06/2011
`
`Reference ID: 2956531
`
`
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