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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 21-038/S-010
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`Hospira Inc.
`275 North Field Drive
`Dept. 0389, Building H2
`Lake Forest, IL 60045-5046
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`Attention: Tracy Lynch
`Manager, Global Regulatory Affairs
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`Dear Ms. Lynch:
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`Please refer to your supplemental new drug application dated December 18, 2007, and received
`December 19, 2007, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for
`Precedex (dexmedetomidine hydrochloride) injection.
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`Reference is also made to your amendments dated January 31, February 13, April 17, May 6, August
`26, and October 10, 2008.
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`This supplemental new drug application provides for the use of Precedex Injection for sedation of non-
`intubated patients prior to and/or during surgical and other procedures.
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`We have completed our review of this application, as amended, and 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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`The final printed labeling (FPL) must be identical to the enclosed labeling text for the package insert
`and carton and container labeling.
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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, please submit the 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 that is identical to the enclosed labeling text for the
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`package insert. Upon receipt, we will transmit that version to the National Library of Medicine for
`public dissemination. For administrative purposes, please designate this submission, “SPL for
`approved NDA 21-038/S-010.”
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`NDA 21-038/S-010
`Page 2
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` CARTON AND IMMEDIATE CONTAINER LABELS
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`Submit final printed carton and 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 titled Providing Regulatory
`Submissions in Electronic Format – Human Pharmaceutical Product Applications and Related
`Submissions Using the eCTD Specifications (October 2005). 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 21-038/S-010.” Approval of this submission by FDA is not required before the
`labeling is used.
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`Marketing the product 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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`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.
`We are deferring submission of your pediatric study until December 31, 2012, because this product is
`ready for approval for use in adults and the pediatric study has not been completed.
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`Your deferred pediatric study required under section 505B(a) of the Federal Food, Drug, and Cosmetic
`Act is a required postmarketing study. The status of this postmarketing study must be reported
`annually according to 21 CFR 314.81 and section 505B(a)(3)(B) of the Federal Food, Drug, and
`Cosmetic Act. This required study is listed below.
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`1. Deferred pediatric study under PREA for the treatment of sedation of non-intubated patients prior
`to and/or during surgical and other procedures in pediatric patients 0 to 16 years of age.
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` Final Report Submission: December 31, 2012
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`Submit final study reports to this NDA. For administrative purposes, all submissions related to this
`required pediatric postmarketing study must be clearly designated “Required Pediatric Assessment”.
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`PROMOTIONAL MATERIALS
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`In addition, submit three copies of the introductory promotional materials that you propose to use for
`this product. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to
`this the Division of Anesthesia, Analgesia, and Rheumatology Products and two copies of both the
`promotional materials and the package insert directly 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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`NDA 21-038/S-010
`Page 3
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` LETTERS TO HEALTH CARE PROFESSIONALS
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`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
`Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to
`the following address:
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` MEDWATCH
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`Food and Drug Administration
`Suite 12B05
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`5600 Fishers Lane
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`Rockville, MD 20857
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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,
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` {See appended electronic signature page}
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`Rigoberto Roca, M.D.
`Deputy Director
`Division of Anesthesia, Analgesia, and
`Rheumatology Products
`Office of Drug Evaluation II
`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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`---------------------
`Rigoberto Roca
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`10/17/2008 04:46:48 PM
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