Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS withdrawal · 2015-12-31Clinical Trial Update: Beta Blockers for Treatment of Pulmonary Arterial Hypertension in Children [Phase 1, Phase 2]
A Phase 1/2 pediatric trial evaluating beta blockers for pulmonary arterial hypertension was withdrawn.
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FDA approval · 2015-12-21FDA Approved: UPTRAVI — Original Application (Actelion Pharmaceuticals US, Inc.)
FDA approved UPTRAVI (selexipag) from Actelion Pharmaceuticals US, Inc. as the original approval for the treatment of pulmonary arterial hyp…
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FDA approval · 2015-12-17FDA Approved: SILDENAFIL — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved Torrent Pharmaceuticals Limited's supplemental application for sildenafil (generic).
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FDA approval · 2015-12-04FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for ADEMPAS (riociguat) from Bayer HealthCare Pharmaceuticals Inc. This action updates the exist…
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FDA approval · 2015-12-04FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for TRACLEER (bosentan) from Actelion to update the drug's labeling.
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CLINICAL_TRIALS withdrawal · 2015-12-02Clinical Trial Update: Evaluating Pulmonary Arterial Hypertension in Patients With Systemic Sclerosis [NA]
A clinical trial evaluating pulmonary arterial hypertension in patients with systemic sclerosis has been withdrawn.
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FDA approval · 2015-11-19FDA Approved: SILDENAFIL — Supplemental Application (Eugia US LLC)
FDA approves a supplemental application for sildenafil citrate by Eugia US LLC (ANDA 203988) for a generic sildenafil product.
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FDA approval · 2015-11-18FDA Approved: SILDENAFIL — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's Original Application for sildenafil, granting a generic version of sildenafil tablets.
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FDA approval · 2015-11-17FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) filed by Actelion Pharmaceuticals US, Inc.
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CLINICAL_TRIALS trial_result · 2015-11-04Clinical Trial Update: Characterization of LV Strain Patterns in Mildly Elevated PCWP and PAH. [Phase 4]
Phase 4 trial update characterizes left ventricular strain patterns in patients with mildly elevated pulmonary capillary wedge pressure and …
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CLINICAL_TRIALS trial_result · 2015-10-26Clinical Trial Update: Post Marketing Observational Study in Patients With Pulmonary Arterial Hypertension
This entry notes the completion of a post-marketing observational study in patients with pulmonary arterial hypertension sponsored by Eli Li…
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FDA approval · 2015-10-26FDA Approved: SILDENAFIL — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for sildenafil from Macleods Pharmaceuticals Limited. This action updates the already approved produ…
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FDA approval · 2015-10-02FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for LETAIRIS (ambrisentan) from Gilead Sciences, Inc.
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FDA approval · 2015-09-25FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for LETAIRIS (ambrisentan) submitted by Gilead Sciences, Inc., updating the drug’s labeling as p…
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FDA approval · 2015-09-16FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for sildenafil citrate by Mylan Pharmaceuticals Inc., supporting its generic sildenafil citrate prod…
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CLINICAL_TRIALS withdrawal · 2015-09-07Clinical Trial Update: Study to Assess Acute Vasodilation Response of Inhaled Nitric Oxide [Phase 3]
A Phase 3 trial evaluating acute vasodilation response to inhaled nitric oxide in pulmonary arterial hypertension has been withdrawn by the …
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CLINICAL_TRIALS trial_result · 2015-08-04Clinical Trial Update: Influence of OATP1B1 and CYP2C9 Genotypes on the Pharmacokinetics of Bosentan Before and During Clarithromycin
A completed pharmacokinetics study evaluating how OATP1B1 and CYP2C9 genotypes influence bosentan exposure before and during co-administrati…
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CLINICAL_TRIALS trial_result · 2015-07-21Clinical Trial Update: Role of Endothelin-A (ETA) and Endothelin-B (ETB) Receptors in the Vasodilatory Response to Endothelin-3 (ET-3) [EARLY_Phase 1]
A Phase 1 study from the University of Edinburgh evaluated the roles of ETA and ETB receptors in the vasodilatory response to endothelin-3 i…
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CLINICAL_TRIALS trial_result · 2015-07-13Clinical Trial Update: Extension to CQTI571A2102 to Evaluate Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH) [Phase 3]
Phase 3 extension study evaluating long-term safety, tolerability, and efficacy of imatinib in severe pulmonary arterial hypertension. The t…
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FDA approval · 2015-06-23FDA Approved: TYVASO — Supplemental Application (United Therapeutics Corporation)
FDA approved a supplemental application for TYVASO (treprostinil) submitted by United Therapeutics Corporation. The action updates the produ…
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FDA approval · 2015-06-04FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for REVATIO (sildenafil citrate) submitted by Viatris Specialty LLC.
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CLINICAL_TRIALS trial_result · 2015-06-02Clinical Trial Update: Influence of Cytochrome CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Ambrisentan
A clinical trial update reported results on how CYP3A4 induction by St. John's Wort alters the steady-state pharmacokinetics of ambrisentan,…
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CLINICAL_TRIALS trial_result · 2015-06-02Clinical Trial Update: Influence of CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Bosentan
A pharmacokinetic study assessed how induction of CYP3A4 by St. John's Wort alters the steady-state exposure of bosentan, informing potentia…
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CLINICAL_TRIALS trial_result · 2015-05-21Clinical Trial Update: Extension to QTI571A2301 to Evaluate the Long-term Safety, Tolerability and Efficacy of Imatinib in Severe Pulmonary Arterial Hypertension (PAH) [Phase 3]
Extension of the Phase 3 QTI571A2301 trial evaluating imatinib for severe pulmonary arterial hypertension to assess long-term safety, tolera…
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CLINICAL_TRIALS trial_result · 2015-05-12Clinical Trial Update: Efficacy Study of Ambrisentan in Chinese Patients With Pulmonary Arterial Hypertension (PAH) [Phase 3]
Phase 3 efficacy study of ambrisentan in Chinese patients with pulmonary arterial hypertension has completed and posted results.