Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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FDA approval · 2019-10-18FDA Approved: ORENITRAM — Supplemental Application (United Therapeutics Corporation)
The FDA approved a supplemental application for ORENITRAM (treprostinil) submitted by United Therapeutics Corporation. The action updates th…
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FDA approval · 2019-09-26FDA Approved: TREPROSTINIL — Original Application (Teva Parenteral Medicines, Inc.)
FDA approved Teva Parenteral Medicines’ TREPROSTINIL as an Original Application, confirming a generic treprostinil product for pulmonary art…
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FDA approval · 2019-09-04FDA Approved: UPTRAVI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for UPTRAVI (selexipag) submitted by Actelion Pharmaceuticals US, Inc.
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FDA approval · 2019-08-23FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for LETAIRIS (ambrisentan) by Gilead Sciences, Inc.
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FDA approval · 2019-06-10FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc.
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FDA approval · 2019-05-31FDA Approved: SILDENAFIL — Original Application (ANI Pharmaceuticals, Inc.)
FDA approves ANI Pharmaceuticals' sildenafil citrate as a generic drug under an original application.
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FDA approval · 2019-05-16FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for TRACLEER (bosentan) filed by Actelion Pharmaceuticals US, Inc., resulting in updated labeling.
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FDA approval · 2019-05-16FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for TRACLEER (bosentan) from Actelion Pharmaceuticals US, Inc., marking an update to the drug's labe…
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FDA approval · 2019-04-26FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for TRACLEER (bosentan) from Actelion Pharmaceuticals US, Inc., resulting in an updated labeling…
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FDA approval · 2019-04-26FDA Approved: BOSENTAN — Original Application (Actavis Pharma, Inc.)
FDA approved a generic bosentan from Actavis Pharma under an original ANDA (ANDA207110). The approval covers its use for pulmonary arterial …
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FDA approval · 2019-04-26FDA Approved: AMBRISENTAN — Original Application (Cipla USA Inc.)
FDA approved Cipla USA Inc.'s original application for Ambrisentan as a generic version, for treatment of pulmonary arterial hypertension.
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FDA approval · 2019-04-26FDA Approved: BOSENTAN — Original Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved Zydus Pharmaceuticals USA Inc.'s Original Application for bosentan, authorizing a generic bosentan product.
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FDA approval · 2019-04-26FDA Approved: BOSENTAN — Original Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved Sun Pharmaceutical Industries' original application for Bosentan, enabling a generic version of the endothelin receptor ant…
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FDA approval · 2019-04-23FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approves a supplemental application for OPSUMIT (macitentan) from Actelion Pharmaceuticals US, Inc., related to the existing macitentan …
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FDA approval · 2019-04-10FDA Approved: AMBRISENTAN — Original Application (Sigmapharm Laboratories, LLC)
FDA approved a generic version of ambrisentan (original application) from Sigmapharm Laboratories for pulmonary arterial hypertension.
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FDA approval · 2019-04-02FDA Approved: SILDENAFIL — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for sildenafil submitted by Torrent Pharmaceuticals Limited.
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FDA approval · 2019-03-28FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for LETAIRIS (ambrisentan) filed by Gilead Sciences, expanding its labeling related to treatment of …
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FDA approval · 2019-03-28FDA Approved: AMBRISENTAN — Original Application (Actavis Pharma, Inc.)
FDA approved the original application for ambrisentan (generic) submitted by Actavis Pharma, enabling the generic version to be marketed. Th…
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FDA approval · 2019-03-28FDA Approved: AMBRISENTAN — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved the original ANDA for ambrisentan from Sun Pharmaceutical Industries, Inc., granting a generic version of the drug. Ambrisentan…
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FDA approval · 2019-03-28FDA Approved: AMBRISENTAN — Original Application (Zydus Lifesciences Limited)
FDA approves the original ANDA for Ambrisentan from Zydus Lifesciences Limited, providing a generic option for use in pulmonary arterial hyp…
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FDA approval · 2019-03-28FDA Approved: AMBRISENTAN — Original Application (Mylan Pharmaceuticals Inc.)
FDA approved Mylan's original application for AMBRISENTAN (ambrisentan), a generic treatment for pulmonary arterial hypertension.
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FDA approval · 2019-03-26FDA Approved: TADALAFIL — Original Application (Aurobindo Pharma Limited)
The FDA approved the original ANDA for tadalafil from Aurobindo Pharma Limited, enabling a generic version of tadalafil to be marketed in th…
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FDA approval · 2019-03-26FDA Approved: TADALAFIL — Original Application (Qilu Pharmaceutical Co., Ltd.)
FDA approved a generic tadalafil (TADALAFIL) from Qilu Pharmaceutical Co., Ltd. under an original ANDA.
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FDA approval · 2019-03-26FDA Approved: TADALAFIL — Original Application (Torrent Pharmaceuticals Limited)
FDA approved Torrent Pharmaceuticals Limited's generic tadalafil tablet under an Original Application (ANDA).
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FDA approval · 2019-03-26FDA Approved: TADALAFIL — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' generic tadalafil under an Original Application (ANDA 209908). The approval covers tadalafil for erecti…