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`APPROVAL LETTER
`
`
`Erin Wierzbicki, MS
`Sr. Associate
`
`Hospira Inc., a Pfizer company
`275 North Field Drive
`Bldg H1
`Lake Forest, IL 60045
`
`Attention:
`
`
`
`Dear Ms. Wierzbicki:
`
`
`Please refer to your supplemental new drug application (sNDA) dated October 7, 2019,
`received October 7, 2019, and your amendments, submitted under section 505(b) of the
`Federal Food, Drug, and Cosmetic Act (FDCA) for Precedex (dexmedetomidine
`hydrochloride injection).
`
`This Prior Approval supplemental new drug application provides for a new 250 mL
`presentation and new drug product manufacturing facility
`
`APPROVAL & LABELING
`
`We have completed our review of this application, as amended. It is approved, effective
`
` on the date of this letter, for use as recommended in the enclosed agreed-upon
`labeling.
`
`We note that your December 20, 2019, submission includes final printed labeling (FPL)
`for your Prescribing Information. We have not reviewed this FPL. You are responsible
`for assuring that the wording in this printed labeling is identical to that of the approved
`content of labeling in the structured product labeling (SPL) format.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the
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`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
`FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
`Prescribing Information, Patient Package Insert, Instructions for Use, 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.
`
`
` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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`
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`Reference ID: 4554684
`
`(b) (4)
`
`
`
`NDA 21038/S-035
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`Page 2
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`Information on submitting SPL files using eList may be found in the guidance for
`
` industry SPL Standard for Content of Labeling Technical Qs and As.2
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`The SPL will be accessible from publicly available labeling repositories.
`
`Also within 14 days, amend all pending supplemental applications that include 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 Microsoft Word
`format, that includes the changes approved in this supplemental application, as well as
`annual reportable changes. 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 CONTAINER LABELING
`
`
`We acknowledge your December 20, 2019, submission containing final printed carton
`and container labeling.
`
`We remind you that you must comply with the requirements for an approved NDA set
`forth under 21 CFR 314.80 and 314.81.
`
`If you have any questions, call Allison Meyer, Regulatory Project Manager, at 301-796-
`1258.
`
`
`Sincerely,
`{See appended electronic signature page}
`
`Rigoberto Roca, MD
`Acting Director
`
`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
`
`
`
`
`2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
`Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.
`
`U.S. Food and Drug Administration
`
`
`Silver Spring, MD 20993
`
`www.fda.gov
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`Reference ID: 4554684
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`
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`
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`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
`01/31/2020 09:05:18 AM
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`Reference ID: 4554684
`
`(
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