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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
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`Food and Drug Administration
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`Rockville, MD 20857
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`NDA 21-880/S-006
`NDA 21-880/S-016
`NDA 21-880/S-017
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`Celgene Corporation
`Attention: Michael Faletto, Ph.D.
`Senior Director, Regulatory Affairs, Oncology
`86 Morris Avenue
`Summit, New Jersey 07901
`
`
`Dear Dr. Faletto:
`
`Please refer to your supplemental new drug applications S-006 dated April 30, 2007 (received
`May 1, 2007), S-016 dated December 8, 2008 (received December 12, 2008), and S-017 dated
`December 22, 2008 (received December 24, 2008) submitted under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act for Revlimid® (lenalidomide) Capsules.
`
`We also acknowledge receipt of your submissions dated July 27, December 28, 2007; March 21,
`June 9, September 2, and October 23 (electronic), 2008.
`
`SLR-006 provides for revisions to the package insert. Based on the results of the pharmacokinetic
`study in patients with renal impairment, lenalidomide starting dose adjustments are recommended
`for patients with CLcr < 60 mL/min.
`
`SLR-016 provides a revised package insert.
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`SLR-017 provides for revisions to the package insert to clarify the starting dose adjustment in
`patients with moderate or severe renal impairment and in patients on dialysis.
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`We have completed the review of these applications, as amended. These applications are
`approved, effective on the date of this letter, for use in the agreed-upon labeling text.
`
`Include content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format as
`described at http://www.fda.gov/oc/datacouncil/spl.html.
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`NDA 21-880/S-006
`NDA 21-880/S-016
`NDA 21-880/S-017
`Page 2
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`If you have any questions, call Carl Huntley, Regulatory Project Manager, at (301) 796-1372.
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`Enclosure:
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`Sincerely,
`
` {See appended electronic signature page}
`
`Robert L. Justice, M.D.
`Division Director
`Division of Drug Oncology Products
`Office of Oncology Drug Products
`Center for Drug Evaluation and Research
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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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`---------------------
`Robert Justice
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`2/23/2009 06:15:29 PM
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