Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-04-04FDA Approved: AMBRISENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for ambrisentan submitted by Sun Pharmaceutical Industries, Inc. The action concerns an update t…
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FDA approval · 2025-04-04FDA Approved: AMBRISENTAN — Supplemental Application (Sigmapharm Laboratories, LLC)
FDA approved a supplemental application for Ambrisentan from Sigmapharm Laboratories, LLC under an ANDA.
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FDA approval · 2025-04-04FDA Approved: AMBRISENTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for a generic version of ambrisentan, used to treat pulmonary arterial hypertension. Mylan Pharmaceu…
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FDA approval · 2025-04-04FDA Approved: AMBRISENTAN — Supplemental Application (Cipla USA Inc.)
FDA approved a supplemental application for Ambrisentan from Cipla USA Inc. under ANDA 210715.
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FDA approval · 2025-04-04FDA Approved: AMBRISENTAN — Supplemental Application (Zydus Lifesciences Limited)
FDA approves a supplemental application from Zydus Lifesciences Limited for ambrisentan, granting regulatory approval of a generic version. …
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FDA approval · 2025-04-04FDA Approved: AMBRISENTAN — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Ambrisentan submitted by Aurobindo Pharma Limited under ANDA216531. This pertains to the gen…
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FDA approval · 2025-04-02FDA Approved: TRYVIO — Supplemental Application (Idorsia Pharmaceuticals Ltd)
The FDA approved a supplemental application for TRYVIO (aprocitentan) from Idorsia Pharmaceuticals Ltd, expanding its regulatory approval.
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FDA approval · 2025-04-02FDA Approved: OPSYNVI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA page indicates a supplemental application (AP) for OPSYNVI, a fixed-dose combination of macitentan and tadalafil, submitted by Actelion …
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FDA approval · 2025-04-02FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) filed by Actelion Pharmaceuticals US, Inc., resulting in approved chang…
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FDA approval · 2025-03-24FDA Approved: SILDENAFIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)
FDA approved a supplemental application for sildenafil submitted by Quallent Pharmaceuticals Health LLC.
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FDA approval · 2025-03-18FDA Approved: SILDENAFIL — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for sildenafil from Aurobindo Pharma Limited. This confirms approval of a generic sildenafil product…
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FDA approval · 2025-03-06FDA Approved: SILDENAFIL — Original Application (Jubilant Cadista Pharmaceuticals Inc.)
FDA approves Jubilant Cadista Pharmaceuticals' generic sildenafil (sildenafil citrate) via an original ANDA.
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FDA approval · 2025-02-28FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc. The approval involves change…
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FDA approval · 2025-02-21FDA Approved: BOSENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved a supplemental application for Bosentan from Sun Pharmaceutical, approving a generic version of bosentan for treating pulmonary…
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FDA approval · 2025-02-21FDA Approved: BOSENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Bosentan by Actavis Pharma, enabling a generic version of the pulmonary arterial hypertension me…
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FDA approval · 2025-02-21FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for TRACLEER (bosentan) by Actelion Pharmaceuticals US, Inc.
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FDA approval · 2025-02-21FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for TRACLEER (bosentan) filed by Actelion Pharmaceuticals US, Inc., resulting in updated labelin…
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FDA approval · 2025-02-21FDA Approved: BOSENTAN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved a supplemental application for bosentan submitted by Lupin Pharmaceuticals, Inc.
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FDA approval · 2025-02-21FDA Approved: BOSENTAN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application to authorize a generic bosentan product (BOSENTAN) from Zydus Pharmaceuticals USA Inc.
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FDA approval · 2025-02-19FDA Approved: TADALAFIL — Supplemental Application (Alembic Pharmaceuticals Inc.)
FDA approved a supplemental application for tadalafil from Alembic Pharmaceuticals Inc., enabling a generic tadalafil product. The approval …
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FDA approval · 2025-02-05FDA Approved: BOSENTAN — Original Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' original application for a generic Bosentan, enabling a generic version of the endothelin receptor a…
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FDA approval · 2025-01-23FDA Approved: BOSENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Bosentan from Actavis Pharma, authorizing a generic version under ANDA207110.
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FDA approval · 2024-12-16FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
The FDA has approved a supplemental application for REVATIO (sildenafil citrate) submitted by Viatris Specialty LLC.
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FDA approval · 2024-12-16FDA Approved: REVATIO — Supplemental Application (PFIZER LABORATORIES DIV PFIZER INC)
The FDA approved a supplemental application for Revatio (sildenafil citrate) submitted by Pfizer Laboratories, indicating an update/expansio…
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FDA approval · 2024-12-12FDA Approved: OPSYNVI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA supplemental application for OPSYNVI (macitentan and tadalafil) by Actelion Pharmaceuticals US, Inc. seeks regulatory action on NDA21849…