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`{ /1_ II U.S. FOOD & DRUG
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`A D MIN I STRATION
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` NDA 020845/S-021
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` APPROVAL LETTER
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`Mallinckrodt Hospital Products IP Unlimited Company
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`Attention: Kristan Amicone
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`Senior Director, Regulatory Affairs
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`90 Washington Valley Road
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`Bedminster, NJ 07921
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`Dear Kristan Amicone:
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`Please refer to your Supplemental New Drug Application (sNDA) dated and received
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`September 22, 2022, and your amendments, submitted under section 505(b) of the
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`Federal Food, Drug, and Cosmetic Act (FDCA) for INOmax (nitric oxide) gas.
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`This Prior Approval supplemental new drug application provides for:
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`A new dosage strength of nitric oxide gas 4880 ppm
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`APPROVAL & LABELING
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`We have completed our review of this supplemental application, as amended. It is
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`approved, effective on the date of this letter, for use as recommended in the enclosed
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`agreed-upon 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, submit the
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`content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
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`the FDA automated drug registration and listing system (eLIST), as described at
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
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`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
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`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 titled SPL Standard for Content of Labeling Technical Qs and As at
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`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guida
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`nces/UCM072392.pdf.
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`The SPL will be accessible via 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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` U.S. Food & Drug Administration
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` Silver Spring, MD 20993
` www.fda.gov
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` NDA 020845/S-021
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` Page 2
` action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format,
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` that includes the changes approved in this supplemental application, as well as annual
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` 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
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` 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 LABELS
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`Submit final printed carton and container labels that are identical to enclosed carton and
`container labels, as soon as they are available, but no more than 30 days after they are
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`printed. Please submit these labels electronically according to the guidance for industry
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`Providing Regulatory Submissions in Electronic Format – Certain Human
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`Pharmaceutical Product Applications and Related Submissions Using the eCTD
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`Specifications. For administrative purposes, designate this submission “Product
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`Correspondence – Final Printed Carton and Container Labels for approved NDA
`020845/S-021.” Approval of this submission by FDA is not required before the labeling
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`is used.
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`We remind you that you must comply with reporting requirements for an approved NDA
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`set forth under 21 CFR 314.80 and 314.81.
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`If you have any questions, call Elizabeth Markovich, Regulatory Business Process
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`Manager, at Elizabeth.Markovich@fda.hhs.gov or (301) 796 - 5071.
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`Sincerely,
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`{See appended electronic signature page}
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`Gurpreet Gill-Sangha, Ph.D.
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`Branch Chief, B3
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`Division of Post-Marketing Activities I
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`Office of Lifecycle Drug Products
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`Office of Pharmaceutical Quality
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`Center for Drug Evaluation and Research
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`Enclosure(s):
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`Content of Labeling
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`Container Labeling
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` U.S. Food & Drug Administration
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` Silver Spring, MD 20993
` www.fda.gov
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`Gurpreet
`Gill Sangha
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`Digitally signed by Gurpreet Gill Sangha
`Date: 1/17/2023 02:34:49PM
`GUID: 5135f2ad000117842392c50c36c7f28a
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`(
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