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`U.S. FOOD & DRUG
`ADMINISTRATION
`
`
`
` NDA 021272/S-032
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`
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`
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` SUPPLEMENT APPROVAL
`
`
`
` United Therapeutics Corp.
`
`
`
` Attention: Nicole Wilkerson
` Associate Director, Regulatory Affairs
`
` 55 TW Alexander Drive, PO Box 14186
`
`
` Research Triangle Park, NC 27709
`
`
`
`
`
` Dear Ms. Wilkerson:
`
` Please refer to your supplemental new drug application (sNDA) dated March 30, 2021,
`
`
`
`
`
` received March 30, 2021, and your amendments, submitted under section 505(b) of the
` Federal Food, Drug, and Cosmetic Act (FDCA) for Remodulin (treprostinil) injection.
`
`
`
`
` This Prior Approval sNDA provides for a new dosage strength, 20mg/mL, of Remodulin
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`
`
`
`
`
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` (treprostinil) with associated revisions to Sections 3, 11, and 16 of the Package Insert.
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`
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` Carton and container labels for the 20 mg/mL strength were also provided.
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`
`
`
`
`
` APPROVAL & LABELING
`
` We have completed our review of this application, as amended. It is approved, effective
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`
`
`
`
`
` on the date of 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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`
`
`
`
`
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` content of labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using
`
` the FDA automated drug registration and listing system (eLIST), as described at
`
` FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the
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`
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`Prescribing Information), with the addition of any labeling changes in pending “Changes
`Being Effected” (CBE) supplements, as well as annual reportable changes not included
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`
`
` in the enclosed labeling.
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`
`
`
`
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` CARTON AND CONTAINER LABELING
`
` Submit final printed carton and container labeling that are identical to theenclosed
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`
`
`
`
`
`
` carton and container labeling or carton and container labeling submitted on July 12,
` 2021, as soon as they are available, but no more than 30 days after they are printed.
`
`
`
`
`
`Reference ID: 4834202
`
`

`

`
` NDA 021272/S-032
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` Page 2
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`
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` Please submit these labeling electronically according to the guidance for industry
`
`
`Providing Regulatory Submissions in Electronic Format — Certain Human
`
`
`
`Pharmaceutical Product Applications and Related Submissions Using the eCTD
`Specifications. For administrative purposes, designate this submission “Product
`
`
`Correspondence – Final Printed Carton and Container Labeling for approved NDA
`
`
` 021272/S-032.” Approval of this submission by FDA is not required before the labeling
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`
`
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` is used.
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` We remind you that you must comply with the requirements for an approved NDA set
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`
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` forth under 21 CFR 314.80 and 314.81.
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` If you have any questions, please call Brian Cooney, Regulatory Project Manager, at
`
` (301) 796-0886.
`
`
`
`
`
`
`
` Sincerely,
`
`
`
` {See appended electronic signature page}
`
`
`
`
`
` Mary Ross Southworth, PharmD
`
` Deputy Director for Safety
` Division of Cardiology and Nephrology
`
` Office of Cardiology, Hematology, Endocrinology,
`
` and Nephrology
` Office of New Drugs
`
` Center for Drug Evaluation and Research
`
`
`
`
`
` ENCLOSURES:
`
`• Content of Labeling
`o Prescribing Information
`• Carton and Container Labeling
`
` U.S. Food and Drug Administration
`
`
` Silver Spring, MD 20993
`
` www.fda.gov
`
`
`
`Reference ID: 4834202
`
`

`

`Signature Page 1 of 1
`--------------------------------------------------------------------------------------------
`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.
`--------------------------------------------------------------------------------------------
`/s/
`------------------------------------------------------------
`
`MARY R SOUTHWORTH
`07/30/2021 11:58:31 AM
`
`Reference ID: 4834202
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