Orenitram Approval History

  • FDA approved: Yes (First approved December 20th, 2013)
  • Brand name: Orenitram
  • Generic name: treprostinil
  • Company: United Therapeutics Corporation
  • Treatment for: Pulmonary Hypertension

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

FDA Approval History 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

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