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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 019386/S-043
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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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`Baxter Healthcare Corporation
`Attention: Amy Giertych
`Senior Director Global Regulatory Affairs
`1620 Waukegan Road, MPGR-AL
`McGaw Park, IL 60085
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`Dear Ms. Giertych:
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`Please refer to your Supplemental New Drug Application (sNDA) originally submitted
`December 30, 2010 and resubmitted February 17, 2012, under section 505(b) of the Federal
`Food, Drug, and Cosmetic Act (FDCA) for Brevibloc (esmolol hydrochloride), 10 mg per ml and
`20 mg per ml for Injection.
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`The February 17, 2012 submission constituted a complete response to our July 1, 2011, action
`letter.
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`This “Prior Approval” supplemental new drug application provides for revisions to comply with
`the formatting requirements of 21 CFR 201.56(d). Content changes were also made in the
`following sections: 1, 2, 3, 4, 5, 6, 7, 8, 10, and 12. Other editorial and organizational changes
`were made throughout the label.
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`We have completed our review of this supplemental application. 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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`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
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
`of labeling must be identical to the enclosed labeling, 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.
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`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.
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`Reference ID: 3228733
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` NDA 019386/S-043
`Page 2
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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 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).
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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, please call Michael Monteleone, Regulatory Project Manager, at (301)
`796-1952.
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`Sincerely,
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`{See appended electronic signature page}
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`Norman Stockbridge, MD, PhD
`Director
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`Division of Cardiovascular and Renal Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
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` Content of Labeling
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`Reference ID: 3228733
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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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`NORMAN L STOCKBRIDGE
`12/11/2012
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`Reference ID: 3228733
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