Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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FDA label_change · 2025-11-05FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for Tracleer (bosentan) submitted by Actelion Pharmaceuticals US, Inc., approving changes to the dru…
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FDA label_change · 2024-10-25FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
FDA approved a supplemental application for REVATIO (sildenafil citrate) submitted by Viatris Specialty LLC, resulting in changes to the pro…
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FDA label_change · 2024-08-19FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for LETAIRIS (ambrisentan) from Gilead Sciences, resulting in changes to the drug's labeling.
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FDA label_change · 2024-05-30FDA Approved: BOSENTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Bosentan from Zydus Pharmaceuticals USA Inc. The update aligns the generic's labeling with the b…
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FDA label_change · 2024-02-08FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for TRACLEER (bosentan) to update the labeling. Bosentan is used to treat pulmonary arterial hyperte…
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FDA label_change · 2024-02-08FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for TRACLEER (bosentan) to update its labeling, submitted by Actelion Pharmaceuticals US, Inc.
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FDA label_change · 2022-04-29FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a Supplemental Application for TRACLEER (bosentan) to update the drug’s labeling.
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FDA label_change · 2021-01-30FDA Approved: UPTRAVI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for Uptravi (selexipag) to update the labeling; Uptravi is used for pulmonary arterial hypertension …
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FDA label_change · 2020-10-21FDA Approved: VELETRI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for VELETRI (epoprostenol) from Actelion Pharmaceuticals US, Inc., resulting in an update to the…
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FDA label_change · 2019-11-04FDA Approved: BOSENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA supplemental approval for bosentan by Actavis Pharma, Inc. resulting in changes to the product labeling.
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FDA label_change · 2019-01-17FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for REVATIO (sildenafil citrate) submitted by Viatris Specialty LLC.
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FDA label_change · 2019-01-17FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Revatio (sildenafil citrate) submitted by Viatris Specialty LLC, resulting in changes to the…
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FDA label_change · 2018-12-12FDA Approved: VELETRI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for VELETRI (epoprostenol) from Actelion Pharmaceuticals US, Inc., resulting in a labeling update fo…
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FDA label_change · 2017-12-20FDA Approved: UPTRAVI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA lists a supplemental application for UPTRAVI (selexipag) filed by Actelion Pharmaceuticals US, Inc.
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FDA label_change · 2017-09-05FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for TRACLEER (bosentan) to update the product label.
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FDA label_change · 2017-07-31FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Revatio (sildenafil citrate) by Viatris Specialty LLC, resulting in changes to the product l…
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FDA label_change · 2017-05-05FDA Approved: ADCIRCA — Supplemental Application (United Therapeutics Corporation)
The FDA highlights a supplemental application for ADCIRCA (tadalafil) submitted by United Therapeutics Corporation, likely related to labeli…
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FDA label_change · 2016-11-22FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for REVATIO (sildenafil citrate) submitted by Viatris Specialty LLC.
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FDA label_change · 2016-07-18FDA Approved: VELETRI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for VELETRI (epoprostenol) from Actelion Pharmaceuticals US, Inc., leading to changes to its lab…
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FDA label_change · 2016-02-22FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for OPSUMIT (macitentan) with updated labeling.
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FDA label_change · 2015-04-30FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc., resulting in updated labeli…
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FDA label_change · 2015-02-03FDA Approved: REVATIO — Supplemental Application (PFIZER LABORATORIES DIV PFIZER INC)
FDA approved a supplemental application for Revatio (sildenafil citrate) by Pfizer Laboratories Division Pfizer Inc, resulting in an approve…
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FDA label_change · 2014-05-20FDA Approved: TYVASO — Supplemental Application (United Therapeutics Corporation)
FDA approved a supplemental application for Tyvaso (treprostinil) submitted by United Therapeutics Corporation to modify its label and/or in…
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FDA label_change · 2014-03-06FDA Approved: REVATIO — Supplemental Application (PFIZER LABORATORIES DIV PFIZER INC)
The FDA approved a supplemental application for Revatio (sildenafil citrate) from Pfizer Laboratories Div Pfizer Inc.
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FDA label_change · 2014-01-31FDA Approved: REVATIO — Supplemental Application (PFIZER LABORATORIES DIV PFIZER INC)
The FDA approved a supplemental application for REVATIO (sildenafil citrate) filed by Pfizer Laboratories Division Pfizer Inc, resulting in …