` NDA 22387/S-017
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`SUPPLEMENT APPROVAL
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`United Therapeutics Corp.
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`Attention: Sarah Gemberling, PhD, RAC
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`Associate Manager, Regulatory Affairs
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`55 TW Alexander Drive
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`PO Box 14186
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`Research Triangle Park, NC 27709
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`Dear Dr. Gemberling:
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`Please refer to your supplemental new drug application (sNDA) dated June 1, 2020,
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`received June 1, 2020, submitted under section 505(b) of the Federal Food, Drug, and
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`Cosmetic Act (FDCA) for Tyvaso (treprostinil) inhalation solution.
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`This Prior Approval supplemental new drug application provides for a new indication for
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`the treatment of pulmonary hypertension associated with interstitial lung disease (PH­
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`ILD; WHO Group 3) to improve exercise ability.
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`APPROVAL & LABELING
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`We have completed our review of this application. It is approved, effective on the date of
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`this letter, for use as recommended in the enclosed 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
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`FDA.gov.1 Content of labeling must be identical to the enclosed labeling Prescribing
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`Information, and Instructions for Use, with the addition of any labeling changes in
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`pending “Changes Being Effected” (CBE) supplements, as well as annual reportable
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`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
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`industry SPL Standard for Content of Labeling Technical Qs and As.2
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` 1 http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
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` 2 We update guidances periodically. For the most recent version of a guidance, check the FDA Guidance
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` Documents Database https://www.fda.gov/RegulatoryInformation/Guidances/default.htm
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`Reference ID: 4771425
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` NDA 22387/S-017
` 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
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`changes for this NDA, including CBE supplements for which FDA has not yet issued an
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`action letter, with the content of labeling [21 CFR 314.50(l)(1)(i)] in Microsoft Word
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`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
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` 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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` REQUIRED PEDIATRIC ASSESSMENTS
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`Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for
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`new active ingredients (which includes new salts and new fixed combinations), new
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`indications, new dosage forms, new dosing regimens, or new routes of administration
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`are required to contain an assessment of the safety and effectiveness of the product for
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`the claimed indication in pediatric patients unless this requirement is waived, deferred,
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`or inapplicable.
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`We are waiving the pediatric study requirement for this application because necessary
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`studies are impossible or highly impracticable.
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`PROMOTIONAL MATERIALS
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`You may request advisory comments on proposed introductory advertising and
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`promotional labeling. For information about submitting promotional materials, see the
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`final guidance for industry Providing Regulatory Submissions in Electronic and Non-
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`Electronic Format-Promotional Labeling and Advertising Materials for Human
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`Prescription Drugs.3
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`You must submit final promotional materials and Prescribing Information, accompanied
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`by a Form FDA 2253, at the time of initial dissemination or publication
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`[21 CFR 314.81(b)(3)(i)]. Form FDA 2253 is available at FDA.gov.4 Information and
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`Instructions for completing the form can be found at FDA.gov.5
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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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` 3 For the most recent version of a guidance, check the FDA guidance web page at
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` 4 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf
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` 5 http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf
`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
`www.fda.gov
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`Reference ID: 4771425
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` NDA 22387/S-017
` Page 3
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` Your product is a Part 3 combination product (21 CFR 3.2(e)); therefore, you must also
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` comply with postmarketing safety reporting requirements for an approved combination
` product (21 CFR 4, Subpart B). Additional information on combination product
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` postmarketing safety reporting is available at FDA.gov.6
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`If you have any questions, please call Brian Cooney, Regulatory Project Manager, at
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`(301) 796-0886.
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`Sincerely,
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`{See appended electronic signature page}
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`Norman Stockbridge, MD, PhD
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`Director
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`Division of Cardiology and Nephrology
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`Office of Cardiology, Hematology, Endocrinology,
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`and Nephrology
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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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`o Prescribing Information
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`o Instructions for Use
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` 6 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety­
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`reporting-combination-products
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`U.S. Food and Drug Administration
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`Silver Spring, MD 20993
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`www.fda.gov
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`Reference ID: 4771425
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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.
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`/s/
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`NORMAN L STOCKBRIDGE
`03/31/2021 01:37:04 PM
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`Reference ID: 4771425
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