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` NDA 021272/S-030
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`SUPPLEMENT APPROVAL
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` United Therapeutics Corp
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` Attention: Nicole Wilkerson
` Senior Manager, Regulatory Affairs
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` 55 TW Alexander Drive
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` Research Triangle Park, NC 27709
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` Dear Ms. Wilkerson:
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` Please refer to your Supplemental New Drug Application (sNDA) dated and received
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` August 19, 2020, submitted under section 505(b) of the Federal Food, Drug, and
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` Cosmetic Act (FDCA) for Remodulin (treprostinil) Injection.
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` This “Changes Being Effected in 30 Days” supplemental new drug application provides
` for the revision of “sodium citrate” to “sodium citrate dihydrate” in section 11 of the
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` package insert, and carton & container labeling.
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` APPROVAL & LABELING
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`We have completed our review of this supplemental application. It is approved,
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`effective on the date of this letter, for use as recommended in the enclosed agreed-
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`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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`http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm.
`Content of labeling must be identical to the enclosed labeling (text for the prescribing
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`information) with the addition of any labeling changes in pending “Changes Being
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`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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`The SPL will be accessible via publicly available labeling repositories.
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`U.S. Food & Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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` NDA 021272/S-030
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` Page 2
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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 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,
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` 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,
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` 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
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`container labels and carton and container labels submitted on August 19, 2020, as soon
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`as they are available, but no more than 30 days after they are printed. Please submit
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`these labels electronically according to the guidance for industry Providing Regulatory
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`Submissions in Electronic Format – Certain Human Pharmaceutical Product
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`Applications and Related Submissions Using the eCTD Specifications. For
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`administrative purposes, designate this submission “Product Correspondence – Final
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`Printed Carton and Container Labels for approved NDA 021272/S-030.” Approval
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`of this submission by FDA is not required before the labeling is used.
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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, call Abolade (Bola) Adeolu, Regulatory Business Process
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`Manager, at (301) 796 - 4264.
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`Sincerely,
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`{See appended electronic signature page}
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`Ramesh Raghavachari, PhD
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`Chief, Branch I
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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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`Enclosures:
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`Content of Labeling
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`U.S. Food & Drug Administration
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` Silver Spring, MD 20993
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` www.fda.gov
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`Ramesh
`Raghavachari
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`Digitally signed by Ramesh Raghavachari
`Date: 2/16/2021 08:29:53PM
`GUID: 502d0913000029f375128b0de8c50020
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`(
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