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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021880/S-018
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`Food and Drug Administration
`Silver Spring MD 20993
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` SUPPLEMENT APPROVAL
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`Celgene Corporation
`Attention: Marion Ceruzzi, Ph.D.
`Director, Regulatory Affairs
`86 Morris Avenue
`Summit, New Jersey 07901
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`Dear Dr. Ceruzzi:
`
`Please refer to your Supplemental New Drug Application (sNDA) dated February 6, 2009,
`received February 9, 2009, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for REVLIMID® (lenalidomide).
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`We acknowledge receipt of your amendments dated February 11, June 11, and December 11,
`2009; April 9, and October 8, 2010.
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`The April 9, 2010, submission constituted a complete response to our December 11, 2009, action
`letter.
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`This “Prior Approval” supplemental new drug application provides for updated information to
`the package insert with efficacy and safety data from the final analyses from the following
`studies:
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`CC-5013-MM-009 “A Multi-Center, Randomized, Parallel-Group, Double-Blind,
`Placebo-Controlled, Study of CC-5013 Plus Dexamethasone Versus Dexamethasone
`Alone in Previously Treated Multiple Myeloma Patients (United States and Canada)”
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`and
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`CC-5013-MM-010 “A Multi-Center, Randomized, Parallel-Group, Double-Blind,
`Placebo-Controlled, Study of CC-5013 Plus Dexamethasone Versus Dexamethasone
`Alone in Previously Treated Multiple Myeloma Patients (European Union, Australia, and
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`Israel)”.
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`We have completed our review of this supplemental application, as amended. It is approved,
`effective on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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`

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` NDA 021880/S-018
`Page 2
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` CONTENT OF LABELING
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`As soon as possible, but no later than 14 days from the date of this letter, submit, using the FDA
`automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling (text for the package insert, text for the patient package insert)
`and include the labeling changes proposed in any pending “Changes Being Effected” (CBE)
`supplements. Information on submitting SPL files using eLIST may be found in the guidance for
`industry titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`The SPL will be accessible from publicly available labeling repositories.
`Also within 14 days, amend all pending supplemental applications for this NDA, including
`pending “Changes Being Effected” (CBE) supplements, for which FDA has not yet issued an
`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format that
`includes the changes approved in this supplemental application.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.(b)(3)(i)]. Form FDA
`2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html; instructions
`are provided on page 2 of the form. For more information about submission of promotional
`materials to the Division of Drug Marketing, Advertising, and Communications (DDMAC), see
`http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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` NDA 021880/S-018
`Page 3
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`All promotional materials that include representations about your drug product must be promptly
`revised to be consistent with the labeling changes approved in this supplement, including any
`new safety information [21 CFR 314.70(a)(4)]. The revisions in your promotional materials
`should include prominent disclosure of the important new safety information that appears in the
`revised package labeling. Within 7 days of receipt of this letter, submit your statement of intent
`to comply with 21 CFR 314.70(a)(4) to the address above or by fax to 301-847-8444.
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`LETTERS TO HEALTH CARE PROFESSIONALS
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`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA to the following
`address:
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`MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administration
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`10903 New Hampshire Ave
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`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Amy Baird, Regulatory Project Manager, at (301) 796-4969.
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`Sincerely,
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`{See appended electronic signature page}
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`Ann T. Farrell, M.D.
`Acting Director
`Division of Hematology Products
`Office of Oncology Drug Products
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
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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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`ANN T FARRELL
`10/12/2010
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`Reference ID: 2848513
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