g iN U.S. FOOD & DRUG
`
`ADMINISTRATION
`
`‘x
`
`NDA 021038/S-055
`
`Hospira Inc.
`275 North Field Drive
`Bldg. H1-3S
`Lake Forest, IL 60045
`
`SUPPLEMENT APPROVAL
`
`Attention:
`
`Maria Hinklin
`Director, Global Regulatory Sciences
`
`Dear Maria Hinklin:
`
`Please refer to your supplemental new drug application (SNDA) dated and received
`December 15, 2023, and your amendments, submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for Precedex (dexmedetomidine
`hydrochloride) injection.
`
`We acknowledgereceipt of your amendment dated June 14, 2024, which constituted a
`complete responseto our April 15, 2024, actionletter.
`
`This sNDAprovidesfor the following changes:
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`1. New presentations (200 mcg/50 mL, 400 mcg/100 mL, and 1,000 mcg/250 mL
`(4 mcg/mL)) in single-dose flexible containers.
`
`(b) (4)
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`2. Addition of a new drug product manufacturing facility
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`3. Addition of
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`APPROVAL & LABELING
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`(b) (4)
`
`(b) (4)
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`We have completed our review ofthis application, as amended. It is approved, effective
`on the date ofthis letter, for use as recommendedin the enclosed agreed-upon
`labeling.
`
`WAIVER OF 2 PAGE LENGTH REQUIREMENT FOR HIGHLIGHTS
`
`Please note that we have previously granted a waiver of the requirements of 21 CFR
`201.57(d)(8) regarding the length of Highlights of Prescribing Information.
`
`Reference ID: 5461471
`
`

`

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` NDA 021038/S-055
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` Page 2
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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
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`
`
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` the FDA automated drug registration and listing system (eLIST), as described at
` FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`
`
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`Prescribing Information), with the addition of any labeling changes in pending “Changes
`
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`Being Effected” (CBE) supplements, as well as annual reportable changes not included
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`in the enclosed labeling.
`
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`Information on submitting SPL files using eList may be found in the guidance for
`
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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`
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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 include labeling
`
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
`
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`format, that includes the changes approved in this supplemental application, as well as
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`annual reportable changes. To facilitate review of your submission, provide a
`
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`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
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`supplement number(s) and annual report date(s).
`
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`CARTON AND CONTAINER LABELING
`
`We acknowledge your September 20, 2024, submission containing final printed carton
`
`and container labeling.
`
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`PROMOTIONAL MATERIALS
`
`You may request advisory comments on proposed introductory advertising and
`promotional labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`
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`Electronic Format – Promotional Labeling and Advertising in Materials for Human
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`Prescription Drugs.3
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`
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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`
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`
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`
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`
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`
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`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
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` 3 For the most recent version of a guidance, check the FDA guidance web page
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`
`
`
`
`
`
`
`
` athttps://www.fda.gov/media/128163/download.
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`Reference ID: 5461471
`
`

`

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` NDA 021038/S-055
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` Page 3
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` You must submit final promotional materials and Prescribing Information, accompanied
`
`
`
` by a Form FDA 2253, at the time of initial dissemination or publication
` [21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
`
`
`
`
`
`
`Instructions for completing the form can be found at FDA.gov.5
`
`PATENT LISTING REQUIREMENTS
`
`
` Pursuant to 21 CFR 314.53(d)(2) and 314.70(f), certain changes to an approved NDA
`
`submitted in a supplement require you to submit patent information for listing in the
`Orange Book upon approval of the supplement. You must submit the patent information
`required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as
`
`
`
`applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the
`supplement for the patent information to be timely filed (see 21 CFR
`
`314.53(c)(2)(ii)). You also must ensure that any changes to your approved NDA that
`
`
`
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`require the submission of a request to remove patent information from the Orange Book
`
`are submitted to FDA at the time of approval of the supplement pursuant to 21 CFR
`
`
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`314.53(d)(2)(ii)(B) and 314.53(f)(2)(iv).
`
`
`We remind you that you must comply with the requirements for an approved NDA set
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`forth under 21 CFR 314.80 and 314.81.
`
`
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`COMPENDIAL STANDARDS
`
`
`A drug with a name recognized in the official United States Pharmacopeia or official
`
`
`National Formulary (USP-NF) generally must comply with the compendial standards for
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`strength, quality, and purity, unless the difference in strength, quality, or purity is plainly
`
`stated on its label (see FD&C Act § 501(b), 21 USC 351(b)). FDA typically cannot share
`application-specific information contained in submitted regulatory filings with third
`parties, which includes USP-NF. To help ensure that a drug continues to comply with
`compendial standards, application holders may work directly with USP-NF to revise
`official USP monographs. More information on the USP-NF is available on USP’s
`
`website6.
`
`
`
`
`
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
`5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`
`
`6 https://www.uspnf.com/
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`Reference ID: 5461471
`
`

`

`
`
` NDA 021038/S-055
`
` Page 4
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`If you have any questions, email Rachel Jang, PharmD, Regulatory Health Project
`
`Manager, at rachel.jang@fda.hhs.gov.
`
`
`
`
`
`
`
` Sincerely,
`
`
`{See appended electronic signature page}
`
`
`Rigoberto Roca, MD
`
`Director
`Division of Anesthesiology, Addiction Medicine and
`
`Pain Medicine
`
`Office of Neuroscience
`
`
`Center for Drug Evaluation and Research
`
`
`
`ENCLOSURES:
`
`
`
`• Content of Labeling
`
`
`
`o Prescribing Information
`
`
`• Carton and Container Labeling
`
`
`
`
`U.S. Food and Drug Administration
`
`
`
`Silver Spring, MD 20993
`
`
`
`www.fda.gov
`
`
`Reference ID: 5461471
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically. Following this are manifestations of any and all
`electronic signatures for this electronic record.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`RIGOBERTO A ROCA
`10/11/2024 10:18:16 AM
`
`Reference ID: 5461471
`
`