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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-003
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`United Therapeutics Corporation
`Attention: Rex Mauthe
`Senior Vice President, Regulatory Affairs
`P.O. Box 14186
`One Park Drive
`Research Triangle Park, NC 27709
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`Dear Mr. Mauthe:
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`Please refer to your supplemental new drug application dated August 11, 2005, received August 15, 2005, submitted under
`section 505(b) of the Federal Food, Drug, and Cosmetic Act for Remodulin (treprostinil sodium) 1.0, 2.5, 5.0 and 10 mg/ml
`injection.
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`We acknowledge receipt of your submission dated August 11, 2005.
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`This “Changes Being Effected in 30 days” supplemental new drug application provides revised vial and carton labels in
`response to the Division of Drug Marketing, Advertising and Communications (DDMAC) March 31, 2005 guidance letter.
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`We completed our review of this supplemental new drug application. It is are approved, effective on the date of this letter,
`for use as recommended in the final printed labeling (FPL) submitted on August 11, 2005.
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`In addition, submit three copies of the introductory promotional materials that you propose to use for this product. Submit
`all proposed materials in draft or mock-up form, not final print. Send one copy to this division and two copies of both the
`promotional materials and the package insert directly to:
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`Food and Drug Administration
`Center for Drug Evaluation and Research
`Division of Drug Marketing, Advertising, and Communications
`Food and Drug Administration
`5901-B Ammendale Road
`Beltsville, MD 20705-1266
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`We remind you that you must comply with the requirements for an approved NDA set forth under 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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`Norman Stockbridge, M.D., Ph.D.
`Acting Director
`Division of Cardiovascular and Renal Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
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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.
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` /s/
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`Norman Stockbridge
`1/20/2006 06:07:38 PM
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