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` DEPARTMENT OF HEALTH AND HUMAN SERVICES
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` NDA 20845/S-018
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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
` c/o: INO Therapeutics
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` Attention: Mary Ellen Anderson
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` Senior Director, Regulatory Affairs
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` Perryville III Corporate Park
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` 53 Frontage Road, Third Floor, Box 9001
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` Hampton, NJ 08827
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` Dear Ms. Anderson:
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` Please refer to your Supplemental New Drug Application (sNDA) dated October 13, 2015,
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` received October 14, 2015, submitted under section 505(b) of the Federal Food, Drug, and
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` Cosmetic Act (FDCA) for INOmax (nitric oxide) for inhalation.
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` This “Changes Being Effected” supplemental new drug application proposes to include a MR
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` conditional triangle and an appropriate warning “Keep cylinder at 100 gauss or less” label.
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` APPROVAL
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`We have completed our review of this supplemental application and it is approved, effective on
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`the date of this letter.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and promotional
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`labeling. To do so, submit the following, in triplicate, (1) a cover letter requesting advisory
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`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
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`(3) the package insert(s) to:
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`OPDP Regulatory Project Manager
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Office of Prescription Drug Promotion (OPDP)
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`Alternatively, you may submit a request for advisory comments electronically in eCTD format.
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`For more information about submitting promotional materials in eCTD format, see the draft
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`Reference ID: 3912530
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` NDA 20845/S-018
` Page 2
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` Guidance for Industry (available at:
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`http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
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`CM443702.pdf ).
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`REPORTING REQUIREMENTS
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`We remind you that you must comply with reporting requirements for an approved NDA
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`(21 CFR 314.80 and 314.81).
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`If you have any questions, please call Brian Proctor, Regulatory Project Manager, at (240) 402-
`3596.
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`Sincerely,
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`{See appended electronic signature page}
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`Norman Stockbridge, M.D., Ph.D.
`Director
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`Division of Cardiovascular and Renal Products
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`Office of Drug Evaluation I
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`Center for Drug Evaluation and Research
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`Reference ID: 3912530
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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
`04/05/2016
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`Reference ID: 3912530
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