Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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FDA approval · 2023-09-18FDA Approved: STERILE DILUENT FOR TREPROSTINIL — Supplemental Application (Dr.Reddy's Laboratories Inc.,)
The FDA approved a supplemental application from Dr. Reddy's Laboratories for a sterile diluent (water) to accompany treprostinil in injecta…
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FDA approval · 2023-08-29FDA Approved: SILDENAFIL CITRATE — Original Application (ANI Pharmaceuticals, Inc.)
The FDA approved ANI Pharmaceuticals' sildenafil citrate tablets as an original application (ANDA216383), establishing a generic version of …
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FDA approval · 2023-06-06FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for TRACLEER (bosentan) submitted by Actelion Pharmaceuticals US, Inc. This action updates the a…
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FDA approval · 2023-05-26FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc. The submission status is…
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FDA approval · 2023-04-24FDA Approved: TADALAFIL — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for tadalafil filed by Camber Pharmaceuticals, Inc. This action grants an updated approval related t…
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FDA approval · 2023-03-07FDA Approved: REMODULIN — Supplemental Application (United Therapeutics Corporation)
The FDA approved a supplemental application for REMODULIN (treprostinil) submitted by United Therapeutics Corporation.
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FDA approval · 2023-03-03FDA 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 approval · 2023-03-03FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
FDA approves a supplemental application for REVATIO (sildenafil citrate) submitted by Viatris Specialty LLC.
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FDA approval · 2023-02-01FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) from Actelion Pharmaceuticals US, Inc., with the action relating to mod…
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FDA approval · 2023-01-31FDA Approved: REVATIO — Supplemental Application (PFIZER LABORATORIES DIV PFIZER INC)
The FDA approved a supplemental application for REVATIO (sildenafil citrate) submitted by Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2022-12-21FDA Approved: SELEXIPAG — Original Application (Zydus Pharmaceuticals (USA) Inc.)
FDA approved the original ANDA for Selexipag from Zydus Pharmaceuticals (USA) Inc., providing a generic option for treating pulmonary arteri…
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FDA approval · 2022-10-12FDA Approved: ALYQ — Original Application (Teva Pharmaceuticals, Inc.)
The FDA approved ALYQ as Teva's generic tadalafil in an original ANDA approval. The approval covers the same indications as tadalafil, inclu…
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FDA approval · 2022-07-21FDA Approved: AMBRISENTAN — Original Application (Aurobindo Pharma Limited)
FDA approved the Original Application for ambrisentan as a generic version by Aurobindo Pharma Limited. The drug is used for the treatment o…
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FDA approval · 2022-07-07FDA Approved: STERILE DILUENT FOR TREPROSTINIL — Supplemental Application (Dr.Reddy's Laboratories Inc.,)
FDA approved a supplemental application for a sterile diluent for Treprostinil, submitted by Dr. Reddy's Laboratories Inc.
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FDA approval · 2022-05-27FDA Approved: TADALAFIL — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Tadalafil submitted by Aurobindo Pharma Limited. This action adds regulatory approval for th…
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FDA approval · 2022-05-23FDA Approved: TYVASO DPI — Original Application (United Therapeutics Corporation)
FDA approves TYVASO DPI as an Original Application, introducing a dry powder inhalation formulation of treprostinil from United Therapeutics…
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FDA approval · 2022-05-20FDA Approved: TYVASO — Supplemental Application (United Therapeutics Corporation)
The FDA approved a supplemental application for TYVASO (treprostinil) submitted by United Therapeutics Corporation.
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FDA approval · 2022-05-19FDA Approved: AMBRISENTAN — Original Application (Apotex Corp.)
FDA approves Apotex Corp.'s original application for ambrisentan, a generic form of the pulmonary arterial hypertension treatment.
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FDA approval · 2022-05-18FDA Approved: TADALAFIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for tadalafil from Quallent Pharmaceuticals Health LLC. This action concerns the approval of a g…
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FDA approval · 2022-04-29FDA Approved: BOSENTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Bosentan from Zydus Pharmaceuticals USA Inc., enabling a generic version of Bosentan to be m…
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FDA approval · 2022-04-29FDA Approved: SILDENAFIL CITRATE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental application for sildenafil citrate submitted by Ascend Laboratories, LLC, resulting in approval of a generic…
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FDA approval · 2022-04-29FDA Approved: BOSENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Bosentan submitted by Sun Pharmaceutical Industries, Inc. This approval expands the drug's label…
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FDA approval · 2022-04-29FDA Approved: BOSENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for bosentan from Actavis Pharma, enabling a generic version of bosentan to be marketed. This approv…
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FDA approval · 2021-11-04FDA Approved: TADALAFIL — Original Application (Burel Pharmaceuticals, LLC)
The FDA approved a generic tadalafil product under an original ANDA for Burel Pharmaceuticals, LLC.
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FDA approval · 2021-10-25FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for OPSUMIT (macitentan) by Actelion Pharmaceuticals US, Inc. The approval indicates changes request…