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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 022088/S-002
`NDA 022088/S-004
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`NDA 022088/S-005
`NDA 022088/S-007
`NDA 022088/S-010
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` NDA 022088/S-012
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
`
`
`Pfizer Inc.
`Attention: Michelle Yu, M.S., R.A.C.
`Manager, Worldwide Regulatory Strategy
`10646 Science Center Drive
`San Diego, CA 92121
`
`Dear Ms Yu:
`
`Please refer to your Supplemental New Drug Applications (sNDA) dated May 12, 2008, received
`May 13, 2008; dated May 21, 2009, received May 21, 2009; dated May 22, 2009, received May
`22, 2009; dated July 1, 2009, dated received July 1, 2009; dated December 17, 2009, received
`December 17, 2009; and dated June 14, 2010, received June 14, 2010; submitted under section
`505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Torisel (temsirolimus)
`injection, 25 mg/mL.
`
`We acknowledge receipt of your amendments dated July 17, 2009; May 12, 2010; June 18, 2010;
`April 11, 2011, April 28, 2011; May 17, 2011; May 20, 2011(2); May 26, 2011; June 13, 2011
`and June 16, 2011.
`
`This Prior Approval supplemental new drug application (S-002) provides for labeling revisions
`to the Highlights of Prescribing Information, Full Prescribing Information-Warnings and
`Precautions, Adverse Reactions, Drug Interactions, How Supplied and Patient Counseling
`Information Sections of the Package Insert.
`
`This Prior Approval supplemental new drug application (S-004) provides for revisions to the
`Highlights of Prescribing Information, Full Prescribing Information-Warnings and Precautions,
`and Use in Specific Populations Sections of the Package Insert.
`
`This Prior Approval supplemental new drug application (S-005) provides for revisions to the
`Highlights of Prescribing Information, Full Prescribing Information-Dosage and Administration
`and Dosage Forms and Strengths Sections of the Package Insert and to the Carton/Container
`Labeling.
`
`
`Reference ID: 2961865
`
`

`

`
` NDA 022088/S-002
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` NDA 022088/S-004
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` NDA 022088/S-005
`NDA 022088/S-007,
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` NDA 022088/S-010
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` NDA 022088/S-012
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`Page 2
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`This Prior Approval supplemental new drug application (S-007) provides for revisions to the Full
`Prescribing Information-Adverse Reactions Section of the Package Insert.
`
`
`This Prior Approval supplemental new drug application (S-010) provides for revisions to the
`Highlights of Prescribing Information, Full Prescribing Information-Warnings and Precautions
`and Adverse Reactions Sections of the Package Insert.
`
`This Changes Being Effected supplemental new drug application (S-012) provides revisions to
`the Full Prescribing Information-Adverse Reactions Sections of the Package Insert.
`
`We have completed our review of these supplemental applications, as amended. They are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text.
`
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the content of
`labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
`automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert, text for the patient
`package insert, Medication Guide), with the addition of any labeling changes in pending “Changes Being
`
`Effected” (CBE) supplements, as well as annual reportable changes not included in the enclosed labeling.
`
`Information on submitting SPL files using eLIST may be found in the guidance for industry
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`titled “SPL Standard for Content of Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
`
`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications for this NDA, including 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, as well as annual reportable changes and annotate each change. To
`facilitate review of your submission, provide a highlighted or marked-up copy that shows all
`changes, as well as a clean Microsoft Word version. The marked-up copy should provide
`appropriate annotations, including supplement number(s) and annual report date(s).
`
`Reference ID: 2961865
`
`

`

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` NDA 022088/S-002
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` NDA 022088/S-004
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` NDA 022088/S-005
`NDA 022088/S-007,
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` NDA 022088/S-010
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` NDA 022088/S-012
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`Page 3
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`Submit final printed carton and container labels that are identical to the enclosed carton and
`immediate container labels and to the carton and immediate container labels submitted on May
`26, 2011, as soon as they are available, but no more than 30 days after they are printed.
`
`Please submit these labels electronically according to the guidance for industry titled “Providing
`Regulatory Submissions in Electronic Format – Human Pharmaceutical Product Applications
`and Related Submissions Using the eCTD Specifications (June 2008).” Alternatively, you may
`submit 12 paper copies, with 6 of the copies individually mounted on heavy-weight paper or
`similar material. For administrative purposes, designate this submission “Product
`Correspondence – Final Printed Carton and Container Labels for approved
`NDA 022088/S-002, NDA 022088/S-004, NDA 022088/S-005, NDA 022088/S-007,
`NDA 022088/S-010 and NDA 022088/S-012.” Approval of this submission by FDA is not
`required before the labeling is used.
`
`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:
`
`
`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
`
`
`You must submit final promotional materials and package insert(s), accompanied by a Form
`
`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`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.
`
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
`
`
`Reference ID: 2961865
`
`

`

`
`
`Sincerely,
`
` {See appended electronic signature page}
`
`Amna Ibrahim, M.D.
`Deputy Director
`Division of Drug Oncology Products
`Office of Oncology Drug Products
`Center for Drug Evaluation and Research
`
`
` NDA 022088/S-002
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` NDA 022088/S-004
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` NDA 022088/S-005
`NDA 022088/S-007,
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` NDA 022088/S-010
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` NDA 022088/S-012
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`Page 4
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`If you have any questions, call Modupe Fagbami, Regulatory Project Manager, at (301) 796-
`1348.
`
`
`
`ENCLOSURES:
`Content of Labeling
`Carton and Container Labeling
`
`Reference ID: 2961865
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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
`06/16/2011
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`Reference ID: 2961865
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`