Pulmonary Arterial Hypertension
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Sign up freeTop drugs studied for this disease
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FDA approval · 2021-10-25FDA Approved: UPTRAVI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for UPTRAVI (selexipag) from Actelion Pharmaceuticals US, Inc., indicating an updated label or e…
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FDA approval · 2021-08-19FDA Approved: UPTRAVI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for UPTRAVI (selexipag) from Actelion Pharmaceuticals US, Inc.
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FDA approval · 2021-07-30FDA Approved: REMODULIN — Supplemental Application (United Therapeutics Corporation)
The FDA has approved a supplemental application for Remodulin (treprostinil) filed by United Therapeutics Corporation.
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FDA approval · 2021-07-29FDA Approved: UPTRAVI — Original Application (Actelion Pharmaceuticals US, Inc.)
FDA approved UPTRAVI (selexipag) from Actelion Pharmaceuticals US, Inc. in an original application for the treatment of pulmonary arterial h…
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FDA approval · 2021-07-29FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for TRACLEER (bosentan) from Actelion Pharmaceuticals US, Inc., resulting in labeling changes.
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FDA approval · 2021-06-08FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
FDA approves a supplemental application for LETAIRIS (ambrisentan) filed by Gilead Sciences, Inc., resulting in changes to the product's lab…
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FDA approval · 2021-06-08FDA Approved: AMBRISENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for Ambrisentan from Actavis Pharma, Inc., related to its approved generic product.
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FDA approval · 2021-06-08FDA Approved: AMBRISENTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for Ambrisentan from Mylan Pharmaceuticals Inc., indicating regulatory approval of the supplemental …
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FDA approval · 2021-06-08FDA Approved: AMBRISENTAN — Supplemental Application (Zydus Lifesciences Limited)
The FDA approved a supplemental application for ambrisentan from Zydus Lifesciences Limited, resulting in a generic version of ambrisentan b…
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FDA approval · 2021-06-08FDA Approved: AMBRISENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for ambrisentan from Sun Pharmaceutical Industries, Inc., under an ANDA.
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FDA approval · 2021-06-08FDA Approved: AMBRISENTAN — Supplemental Application (Sigmapharm Laboratories, LLC)
FDA approved a supplemental application for a generic version of ambrisentan (AMBRISENTAN) from Sigmapharm Laboratories, LLC.
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FDA approval · 2021-06-08FDA Approved: AMBRISENTAN — Supplemental Application (Cipla USA Inc.)
The FDA approved Cipla USA Inc.'s supplemental application for ambrisentan, allowing the generic version to be marketed in the United States…
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FDA approval · 2021-05-26FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
The FDA approved a supplemental application for OPSUMIT (macitentan) submitted by Actelion Pharmaceuticals US, Inc.
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FDA approval · 2021-05-11FDA Approved: SILDENAFIL — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' original ANDA for a sildenafil powder product, a generic version of sildenafil.
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FDA approval · 2021-03-31FDA Approved: TYVASO — Supplemental Application (United Therapeutics Corporation)
FDA approved a supplemental application for TYVASO (treprostinil) from United Therapeutics Corporation. This approval updates the product la…
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FDA approval · 2021-03-17FDA Approved: TADALAFIL — Supplemental Application (Cipla USA Inc.)
The FDA approved a supplemental application for tadalafil from Cipla USA Inc. under ANDA210255, expanding the approved generic product for a…
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FDA approval · 2021-02-11FDA Approved: TREPROSTINIL — Original Application (Alembic Pharmaceuticals Inc.)
The FDA approved Alembic Pharmaceuticals' original ANDA for treprostinil, enabling the generic version of the drug to be marketed.
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FDA approval · 2021-01-15FDA Approved: EPOPROSTENOL — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved the original ANDA for epoprostenol from Sun Pharmaceutical Industries, Inc., confirming a generic version of the pulmonary arte…
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FDA approval · 2021-01-07FDA Approved: TADALAFIL — Supplemental Application (HEC Pharm USA Inc.)
The FDA approved a supplemental application for tadalafil from HEC Pharm USA Inc., indicating approval of an additional generic tadalafil pr…
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FDA approval · 2020-12-22FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
The FDA approved a supplemental application for LETAIRIS (ambrisentan) from Gilead Sciences, Inc.
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FDA approval · 2020-12-22FDA Approved: AMBRISENTAN — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for ambrisentan (Actavis Pharma, Inc.) under ANDA208252.
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FDA approval · 2020-12-22FDA Approved: AMBRISENTAN — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
The FDA approved a supplemental application for Ambrisentan from Sun Pharmaceutical Industries, Inc.
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FDA approval · 2020-12-22FDA Approved: AMBRISENTAN — Supplemental Application (Sigmapharm Laboratories, LLC)
FDA approved a supplemental application to authorize a generic version of Ambrisentan by Sigmapharm Laboratories, LLC (ANDA 208354).
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FDA approval · 2020-12-22FDA Approved: AMBRISENTAN — Supplemental Application (Cipla USA Inc.)
FDA records a supplemental approval application for ambrisentan submitted by Cipla USA Inc., potentially updating the drug's approval or lab…
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FDA approval · 2020-12-22FDA Approved: AMBRISENTAN — Supplemental Application (Mylan Pharmaceuticals Inc.)
The FDA approved a supplemental application for ambrisentan from Mylan Pharmaceuticals Inc., enabling the generic ambrisentan product under …