`
`NDA 203496/S—007
`
`United Therapeutics Corporation
`Attention: Nicole Wilkerson
`
`Manager, Regulatory Affairs
`55 TW Alexander Drive
`PO. Box 14186
`
`Research Triangle Park, NC 27709
`
`Dear Ms. Wilkerson:
`
`Food and Drug Administration
`Silver Spring MD 20993
`
`SUPPLEMENT APPROVAL
`
`Please refer to your Supplemental New Drug Application (sNDA) dated and received march 27, 2017,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Orenitram
`(treprostinil) 0.125 mg, 0.25 mg, 1 mg, 2.5 mg, and 5 mg Extended Release Tablets.
`
`We also refer to our Approval Letter dated Jlme 7, 2017. The approved labeling was not appended to the
`J1me 7"I letter. This letter corrects that error and supersedes the June 7, 2017 Approval letter. The date of
`approval will remain June 7, 2017.
`
`This supplemental new drug application provides for revisions to the approved Patient Package Insert as
`follows (additions are shown as underlined text and deletions are shown as sfifleethreugh text):
`
`1. Under What are the possible side effects of 0renitram?, the following text was added/deleted:
`
`side efl‘ects have also been
`
`observed in patients
`ess, indi estion,
`
`:
`
`The following
`taking Orenitlam
`vomitin muscle
`
`‘
`
`’
`
`2. The revision date was updated.
`
`APPROVAL & LABELING
`
`We have completed our review of this supplemental application and it is approved, effective on the date
`of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
`
`CONTENT OF LABELING
`
`As soon as possible, but no later than 14 days from the date of this letter, submit the content of labeling
`[21 CFR 314500)] in structured product labeling (SPL) format using the FDA automated drug
`registration and lisn'ng system (eLIST), as described at
`
`Reference ID: 4111034
`
`
`
`NDA 203496/S-007
`Page 2
`
`
`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content of
`labeling must be identical to the enclosed labeling (text for the patient package insert), 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.
`
`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/UCM0723
`92.pdf.
`
`The SPL will be accessible from publicly available labeling repositories.
`
`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 MS Word format, that includes the changes approved in this
`supplemental application, as well as annual 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 Microsoft Word version. The marked-up copy should provide appropriate annotations, including
`supplement number(s) and annual report date(s).
`
`REPORTING REQUIREMENTS
`
`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80
`and 314.81).
`
`If you have any questions, please call:
`
`Lori Anne Wachter, RN, BSN, RAC
`Regulatory Project Manager for Safety
`(301) 796-3975
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Mary Ross Southworth, PharmD.
`Deputy Director for Safety
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`
`ENCLOSURE:
`Content of Labeling
`
`Reference ID: 4111034
`
`
`
`---------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed
`electronically and this page is the manifestation of the electronic
`signature.
`---------------------------------------------------------------------------------------------------------
`/s/
`----------------------------------------------------
`
`MARY R SOUTHWORTH
`06/07/2017
`
`Reference ID: 4111034
`
`