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