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Orenitram Approval History

FDA Approved: Yes (First approved December 20, 2013)
Brand name: Orenitram
Generic name: treprostinil
Dosage form: Extended-Release Tablets
Company: United Therapeutics Corporation
Treatment for: Pulmonary Hypertension

Orenitram (treprostinil extended-release) is an oral prostacyclin for the treatment of pulmonary arterial hypertension.

Development History and FDA Approval Process for Orenitram

DateArticle
Dec 30, 2013Approval FDA Approves Orenitram (treprostinil) Extended-Release Tablets for the Treatment of Pulmonary Arterial Hypertension
Sep 12, 2013United Therapeutics Announces FDA Acceptance of Second Resubmission of Oral Treprostinil NDA

Further information

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