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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 021038/S-019, S-024, and S-026
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`
` Steven Townsend
`Associate Director, Global Regulatory Affairs
`
` Hospira Inc.
`
`275 North Field Drive
`Dept. 392, Bldg. H2-2
`Lake Forest, IL 60064
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`Attention:
`
`
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`Dear Mr. Townsend:
`
`Please refer to your Supplemental New Drug Applications (sNDAs) dated April 20, 2012
`(S-019), August 16, 2013 (S-024), and January 7, 2014 (S-026), received April 20, 2012, August
`19, 2013, and January 7, 2014, respectively, submitted under section 505(b) of the Federal Food,
`Drug, and Cosmetic Act (FDCA) for Precedex (dexmedetomidine hydrochloride).
`
`
`We acknowledge receipt of your amendments dated August 15, 2012, and December 24, 2013
`(S-019), January 17 (S-024), February 7 (S-019 and S-024), and February 14, 2014 (S-026).
`
`Supplement S-019 provides for revisions to the ADVERSE REACTIONS section of the
`Package Insert to include the details of the clinical trial settings for the source of the safety
`information.
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`Supplement S-024 proposes an additional strength (fill size) 80 mcg/20 mL premixed single-use
`vial packaging configuration of Precedex.
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`Supplement S-026 is submitted in response to the Agency’s Prior Approval Supplement Request
`letter dated November 21, 2013.
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`APPROVAL & LABELING
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`We have completed our review of these supplemental applications, as amended, and they are
`approved, effective on the date of this letter, for use as recommended in the enclosed, agreed-
`upon labeling text.
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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 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
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`
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`Reference ID: 3658226
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`

`

`NDA 021038/S-019, S-024, and S-026
`Page 2
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling (text for the package insert and text for the
`patient package insert), 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 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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`Also within 14 days, amend all pending supplemental applications that includes labeling changes
`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).
`
`CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and immediate container labels that are identical to the enclosed
`carton and immediate container labels, 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 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
`“Final Printed Carton and Container Labels for approved NDA 021038/S-024 and S-026.”
`Approval of this submission by FDA is not required before the labeling is used.
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`Marketing the product(s) with FPL that is not identical to the approved labeling text may render
`the product misbranded and an unapproved new drug.
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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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`
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`Reference ID: 3658226
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`

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`NDA 021038/S-019, S-024, and S-026
`Page 3
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Office of Prescription Drug Promotion (OPDP)
`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 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
`Information and Instructions for completing the form can be found at
`http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
`more information about submission of promotional materials to the Office of Prescription Drug
`Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
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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 Allison Meyer, Regulatory Project Manager, at (301) 796-1258.
`
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`Sincerely,
`
`{See appended electronic signature page}
`
`
`Sharon Hertz, MD
`Acting Director
`Division of Anesthesia, Analgesia,
`and Addiction Products
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
`Carton and Container Labeling
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`
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`Reference ID: 3658226
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`

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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/
`----------------------------------------------------
`
`ALLISON MEYER
`11/14/2014
`
`SHARON H HERTZ
`11/14/2014
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`Reference ID: 3658226
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`