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`DEPARTMENT OF HEALTH & HUMAN SERVICES
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`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
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`NDA 21-272/S-005
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`United Therapeutics Corporation
`Attention: Dean Bunce
`P.O. Box 14186
`One Park Drive
`Research Triangle Park, NC 27709
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`Dear Mr. Bunce:
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`Please refer to your supplemental new drug application dated October 12, 2005, received October 13,
`2005, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Remodulin
`Injection (treprostinil sodium) 1.0, 2.5, 5.0, and 10 mg/ml.
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`We acknowledge receipt of your submissions dated February 1, 7, 8, 21 and March 6, 2006.
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`This supplemental new drug application provides a final study report for Phase 4 commitments
`required as a condition of your May 21, 2002 Subpart H approval. Specifically, this supplement
`provides information to the labeling on the use of Remodulin Injection (treprostinil sodium) 1.0, 2.5,
`5.0, and 10 mg/ml for the treatment of patients with pulmonary arterial hypertension (PAH) requiring
`transition from Flolan®.
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`We have completed our review of this application, as amended. This application is approved, effective
`on the date of this letter, for use as recommended in the agreed-upon labeling text.
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`The final printed labeling (FPL) must be identical to the enclosed labeling.
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`The electronic labeling rule published December 11, 2003, (68 FR 69009) requires submission of
`labeling content in electronic format effective June 8, 2004. For additional information, consult the
`following guidances for industry regarding electronic submissions: Providing Regulatory
`Submissions in Electronic Format - NDAs (January 1999) and Providing Regulatory Submissions in
`Electronic Format – Content of Labeling (February 2004). The guidances specify that labeling to be
`submitted in pdf format. To assist in our review, we request that labeling also be submitted in MS
`Word format. If formatted copies of all labeling pieces (i.e., package insert, patient package insert,
`container labels, and carton labels) are submitted electronically, labeling does not need to be submitted
`in paper. For administrative purposes, designate this submission "FPL for approved supplement
`NDA 21-272/S-005.” Approval of this submission by FDA is not required before the labeling is used.
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`We approved this NDA under the regulations at 21 CFR 314 Subpart H for accelerated approval of
`new drugs for serious or life-threatening illnesses. Approval of this supplement fulfills your
`commitments made under 21 CFR 314.510.
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`NDA 21-272/S-005
`Page 2
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`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
`314.80 and 314.81).
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`If you have any questions, please call:
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`Mr. John David
`Regulatory Project Manager
`(301) 796-1059
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`Sincerely,
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`{See appended electronic signature page}
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`Norman Stockbridge, M.D., Ph.D.
`Director
`Division of Cardiovascular and Renal Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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`Enclosure: Agreed upon labeling text
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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/
`---------------------
`Norman Stockbridge
`3/20/2006 03:59:46 PM
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