Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-09-28FDA Approved: UPTRAVI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for UPTRAVI (selexipag) from Actelion Pharmaceuticals US, Inc.
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FDA approval · 2017-09-27FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for LETAIRIS (ambrisentan) by Gilead Sciences, Inc., resulting in changes to the product's labeling …
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FDA approval · 2017-09-05FDA Approved: TRACLEER — Original Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved TRACLEER (bosentan) through its original application filed by Actelion Pharmaceuticals US, Inc. for the treatment of pulmon…
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FDA approval · 2017-08-25FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc., effectively updating/ad…
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FDA approval · 2017-08-17FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for sildenafil citrate filed by Mylan Pharmaceuticals Inc., clearing a pathway for a generic sil…
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FDA approval · 2017-07-31FDA Approved: REVATIO — Supplemental Application (PFIZER LABORATORIES DIV PFIZER INC)
The FDA approved a supplemental NDA for REVATIO (sildenafil citrate) from Pfizer Laboratories Div Pfizer Inc, authorizing changes to the pro…
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FDA approval · 2017-07-31FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for REVATIO (sildenafil citrate) by Viatris Specialty LLC.
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FDA approval · 2017-07-21FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for LETAIRIS (ambrisentan) from Gilead Sciences, Inc., indicating an updated/expanded use or lab…
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FDA approval · 2017-07-21FDA Approved: UPTRAVI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for UPTRAVI (selexipag) by Actelion Pharmaceuticals US, Inc., updating labeling as part of the s…
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FDA approval · 2017-06-07FDA Approved: ORENITRAM — Supplemental Application (United Therapeutics Corporation)
The FDA approved a supplemental application for ORENITRAM (treprostinil) from United Therapeutics Corporation.
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FDA approval · 2017-03-21FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc.
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FDA approval · 2017-02-23FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for ADEMPAS (riociguat) from Bayer HealthCare Pharmaceuticals Inc.
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FDA approval · 2017-01-24FDA Approved: ORENITRAM — Supplemental Application (United Therapeutics Corporation)
The FDA approved a supplemental application for ORENITRAM (treprostinil) filed by United Therapeutics Corporation. The approval represents a…
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FDA approval · 2017-01-17FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for ADEMPAS (riociguat) from Bayer HealthCare Pharmaceuticals Inc., approving a change to the drug's…
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FDA approval · 2016-12-16FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for Tracleer (bosentan) by Actelion Pharmaceuticals US. The approval updates the drug’s labeling and…
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FDA approval · 2016-12-15FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for LETAIRIS (ambrisentan) from Gilead Sciences, Inc., resulting in changes to the product label…
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FDA approval · 2016-10-21FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) from Actelion Pharmaceuticals US, Inc. This action represents an update…
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FDA approval · 2016-10-20FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA has approved a supplemental application for TRACLEER (bosentan) from Actelion Pharmaceuticals US, Inc. to modify or expand its labeling.…
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FDA approval · 2016-10-17FDA Approved: SILDENAFIL — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for sildenafil (generic) from Amneal Pharmaceuticals of New York LLC under an ANDA. The approval all…
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FDA approval · 2016-10-04FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for ADEMPAS (riociguat) submitted by Bayer HealthCare Pharmaceuticals Inc., resulting in an updated …
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FDA approval · 2016-06-15FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc., reflecting an approved …
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FDA approval · 2016-03-22FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) from Actelion Pharmaceuticals US, Inc., authorizing changes to the prod…
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FDA approval · 2016-03-21FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for LETAIRIS (ambrisentan) by Gilead Sciences, Inc., related to labeling or indication updates f…
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FDA approval · 2016-02-17FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) from Actelion Pharmaceuticals US, Inc. The action is part of the supple…
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FDA approval · 2016-01-28FDA Approved: ORENITRAM — Supplemental Application (United Therapeutics Corporation)
The FDA approved a supplemental application for ORENITRAM (treprostinil) from United Therapeutics.