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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 022088/S-008
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Wyeth Pharmaceuticals, Inc.
`Attention: David K. Ellis, Ph.D.
`Assistant Vice President, Global Regulatory Affairs
`35 CambridgePark Drive
`Cambridge, MA 02140
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`Dear Dr. Ellis
`
`Please refer to your Supplemental New Drug Application (sNDA) dated September 10, 2009,
`received September 10, 2009, submitted under section 505(b) of the Federal Food, Drug, and
`Cosmetic Act (FDCA) for TORISEL® (temsirolimus) injection.
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`We acknowledge receipt of your amendments dated April 2 and 12, 2010.
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`This “Prior Approval” supplemental new drug application provides for updates to the package
`insert based upon the trial entitled “A Phase I Pharmacokinetic and Pharmacodynamic Study of
`Temsirolimus (CCI-779) in Patients with advanced Malignancies and Normal and Impaired
`Liver Function: An NCI Organ Dysfunction Working Group Study”.
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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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`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) 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.
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` NDA 022088/S-008
`Page 2
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`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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`REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
`active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
`administration are required to contain an assessment of the safety and effectiveness of the
`product for the claimed indication(s) in pediatric patients unless this requirement is waived,
`deferred, or inapplicable.
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`Because this drug product for this indication has an orphan drug designation, you are exempt
`from this requirement.
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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, in triplicate, a cover letter requesting advisory comments, the
`proposed materials in draft or mock-up form with annotated references, and 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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`As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
`package insert(s), at the time of initial dissemination or publication, accompanied by a Form
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`FDA 2253. For instruction on completing the Form FDA 2253, see 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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`All promotional materials for your drug product that include representations about your drug
`product must be promptly revised to make it consistent with the labeling changes approved in
`this supplement, including any new safety information [21 CFR 314.70(a)(4)]. The revisions to
`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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` NDA 022088/S-008
`Page 3
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`As required under 21 CFR 314.81(b)(3)(i), you must submit your updated final promotional
`materials, and the package insert(s), at the time of initial dissemination or publication,
`accompanied by a Form FDA-2253, directly to the above address. For instruction on completing
`the Form FDA 2253, see page 2 of the Form. For more information about submission of
`promotional materials to the Division of Drug Marketing, Advertising, and Communications
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`(DDMAC), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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
`CDERMedWatchSafetyAlerts@fda.hhs.gov, and 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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`Robert L. Justice, M.D., M.S.
`Director
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`Division of Drug Oncology 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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`Application
`Type/Number
`--------------------
`NDA-22088
`
`Submission
`Type/Number
`--------------------
`SUPPL-8
`
`Submitter Name
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`Product Name
`
`--------------------
`WYETH
`PHARMACEUTICA
`LS INC
`
`------------------------------------------
`TORISEL
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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/
`----------------------------------------------------
`
`AMNA IBRAHIM
`07/09/2010
`For Dr. Justice
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`