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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 020845/S-020
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`Food and Drug Administration
`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`Mallinckrodt Hospital Products IP Limited
`Attention: Stacy Woeppel
`Director, Global Lead - Acute Care
`1425 US Route 206
`Bedminster NJ, 07921
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`Dear Ms. Woeppel:
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`Please refer to your Supplemental New Drug Application (sNDA) dated July 14, 2017, received
`July 14, 2017 and withdrawn on January 8, 2018. Reference is also made to your resubmission
`of this supplement on August 15, 2018, and your amendments, submitted under section 505(b)
`the Federal Food, Drug, and Cosmetic Act (FDCA) for INOmax (nitric oxide) gas, 800 ppm.
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`This Prior Approval supplemental new drug application provides for revisions to labeling
`regarding use in an MRI setting, revisions pursuant to the Pregnancy Lactation and Labeling
`Rule, (PLLR), and revisions with respect to use with Nitric Oxide Delivery Systems.
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. 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 (text for the Prescribing Information), 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 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: 4390474
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`NDA 020845/S-020
`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 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(s), 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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`CARTON AND CONTAINER LABELING
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`We acknowledge your August 15, 2018, submission containing final printed carton and container
`labeling.
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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, Associate Director for Labeling, at
`(301) 796-1952.
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`Cc:
`Mallinckrodt Hospital Products IP Limited
`College Business Park
`Cruiserath Road
`Blanchardstown, Dublin 15
`Ireland
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`ENCLOSURE(S):
`Content of Labeling
`Carton and Container Labeling
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`Reference ID: 4390474
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`Sincerely,
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`{See appended electronic signature page}
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`Norman Stockbridge, MD, PhD
`Director
`Division of Cardiovascular and Renal Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`Signature Page 1 of 1
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`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/
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`NORMAN L STOCKBRIDGE
`02/13/2019 02:20:49 PM
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`Reference ID: 4390474
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