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`DEPARTMENT OF HEALTH AND HUMAN SERVICES
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`NDA 20-845/S-011
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`Food and Drug Administration
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`Silver Spring MD 20993
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`SUPPLEMENT APPROVAL
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`INO Therapeutics
`6 Route 173
`Clinton, New Jersey 08809
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`Attn: Mary Ellen Anderson
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` Senior Director, Regulatory Affairs
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`Dear Ms. Anderson:
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`Please refer to your Supplemental New Drug Application (sNDA) dated June 24, 2010, receiv ed
`June 25, 2010, submitted under section 505(b) o f the Federal Food, Drug, and Cosmetic Act
`(FDCA) for INOmax (nitric oxide) Inhalation.
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`We acknowledge receipt of your amendments dated, November 22, 2010 and, December 13,
`2010.
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`This Prior Approval supplemental new drug application provides for changes to the C linical
`Trials Section in the INOmax label to reflect results from the pediatric study reports.
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`We have completed our review of this supplemental application, as amended. It is approved,
`effect ive on the date of this letter, for use as recommended in the enclosed, agreed-upon labeling
`text.
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`As soon as possible, but no later than 14 days from the date of this letter, submit , using the FDA
`automated drug registration and listing system (eLIST), the content of labeling
`[21 CFR 314.50(l)] in structured product labeling (SPL) format, as described at
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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm, that is
`identical to the enclosed labeling text for the package insert and include the labeling chan ges
`proposed in any pending “Changes Being Effected” (CBE) supplements and any annual
`reportable changes not included in the enclosed labeling. Information on submitting SPL fil es
`using eLIST may be found in the g uidance for industry titled “SPL Standard for Content of
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`Labeling Technical Qs and As” at
`http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
`CM072392.pdf.
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`Reference ID: 2881485
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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 for this NDA, including C BE
`supplements for which FDA has not yet issued an action letter, with the content of labeli ng
`[21 CFR 314.50(l)(1)(i)] in MS Word format that includes the changes approved in this
`supplemental application.
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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
`comments, (2) the proposed materials in draft or mock-up form with annotated references, and
`(3) the package insert(s) to:
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`Food and Drug Administration
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`Center for Drug Evaluation and Research
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`Division of Drug Marketing, Advertising, and Communications
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`5901-B Ammendale Road
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`Beltsville, MD 20705-1266
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`You must submit final promotional materials and package insert(s), accompanied by a Form
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`FDA 2253, at the time of initial dissemination or publication [21 CFR 314.81(b)(3)(i)]. Form
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`FDA 2253 is available at http://www.fda.gov/opacom/morechoices/fdaforms/cder.html;
`instructions are provided on page 2 of the form. For more information about submission of
`promotional materials to the Division of Drug Marketing, Advertising, and Communications
`(DDMAC), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm .
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`If you decide to issue a letter communicating important safety-related information about this
`drug product (i.e., a “Dear Health Care Professional” letter), we request that you submit, at least
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`24 hours prior to issuing the letter, an electronic copy of the letter to this NDA to the following
`address:
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`MedWatch Program
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`Office of Special Health Issues
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`Food and Drug Administratio n
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`10903 New Hampshire Ave
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`Building 32, Mail Stop 5353
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`Silver Spring, MD 20993
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`We remind you that you must c omply with reporting requirements for an approved NDA
`(21 CFR 314.80 and 314.81).
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`If you have any questions, call Angela Ramsey, Senior Regulatory Project Manager, at (301)
`796-2284.
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`Reference ID: 2881485
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`Sincerely,
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`{See appended electronic signature pa ge}
`Lydia Gilbert-McClain, M.D., FCCP
`Deputy Division Director
`Office of Drug Evaluation II
`Center for Drug Evaluation and Research
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`ENCLOSURE(S):
`Content of Labeling
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`Reference ID: 2881485
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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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`LYDIA I GILBERT MCCLAIN
`12/21/2010
`Deputy Division Director
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`Reference ID: 2881485
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