United Therapeutics Announces Probable Delay in Approval Timeline for Inhaled Treprostinil (Tyvaso)
...with the U.S. Food and Drug Administration (FDA), the FDA's pending regulatory review of the New Drug Application (NDA) for Tyvaso (inhaled treprostinil) will likely extend beyond its originally anticipated April 30, 2009, action date. The probable delay relates to questions received from the...
New Drug Applications (FDA) · More like this

U.S. Food and Drug Administration Extends Action Date for Inhaled Treprostinil (Tyvaso) New Drug Application by Three Months
...U.S. Food and Drug Administration (FDA) will require additional time to complete its review of the New Drug Application (NDA) for Tyvaso (inhaled treprostinil). In a notice received today, the FDA extended the Prescription Drug User Fee Act (PDUFA) date from April 30, 2009, to July 30, 2009. United...
New Drug Applications (FDA) · More like this

Remodulin
Remodulin Generic Name: treprostinil sodium Dosage Form: injection FULL PRESCRIBING INFORMATION Remodulin® (treprostinil sodium) Injection Indications and Usage for Remodulin...
Professional Monographs (FDA) · More like this

Triumph-1 Trial of Viveta in Pulmonary Arterial Hypertension Meets Primary Endpoint
...and its wholly-owned subsidiary, Lung Rx, Inc., announced today the completion of their TRIUMPH-1 Phase 3 trial of Viveta, an inhaled formulation of treprostinil, in pulmonary arterial hypertension (PAH). Preliminary analysis demonstrates that the trial has robustly met its primary endpoint. The TRIUMPH-1...
Clinical Trial Results (FDA) · More like this

Results of TRIUMPH-1 Trial of Viveta in Pulmonary Arterial Hypertension to Be Announced Before Market Open on Thursday, November 1, 2007
...subsidiary, Lung Rx, Inc., announced today that they will release the results of their TRIUMPH-1 Phase 3 trial of Viveta, an inhaled formulation of treprostinil, in pulmonary arterial hypertension (PAH) before market open on Thursday, November 1, 2007. United Therapeutics will expand its previously...
Clinical Trial Results (FDA) · More like this

See also: Pulmonary Arterial Hypertension

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