Pulmonary Arterial Hypertension
📧 Sign up to get email alerts when something new happens for Pulmonary Arterial Hypertension.
Sign up freeTop drugs studied for this disease
-
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…
-
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…
-
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.
-
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…
-
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.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
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).
-
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…
-
CLINICAL_TRIALS research · 2019-02-18Clinical Trial Update: Repeatability and Sensitivity to Change of Non-invasive Endpoints in PAH [NA]
Clinical trial update evaluating the repeatability and sensitivity to change of non-invasive endpoints in pulmonary arterial hypertension.
-
CLINICAL_TRIALS trial_result · 2019-02-15Clinical Trial Update: Aerobic Exercise Training in Pulmonary Arterial Hypertension [NA]
This entry notes the completed status of a clinical trial investigating aerobic exercise training in patients with pulmonary arterial hypert…
-
FDA approval · 2019-02-05FDA Approved: TADALAFIL — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' generic tadalafil under an Original Application (ANDA), enabling a new generic version of tadalafil for …
-
CLINICAL_TRIALS trial_result · 2019-02-05Clinical Trial Update: A Pharmacokinetics Study for Pediatric Participants With Pulmonary Arterial Hypertension [Phase 1, Phase 2]
A pharmacokinetics study in pediatric participants with pulmonary arterial hypertension completed Phases 1 and 2, with results posted in 201…
-
FDA approval · 2019-02-01FDA Approved: OPSUMIT — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for OPSUMIT (macitentan) from Actelion Pharmaceuticals US, Inc., resulting in an update to the label…
-
CLINICAL_TRIALS research · 2019-01-18Clinical Trial Update: Prevalence of the Hyperventilation Syndrome in Pulmonary Arterial Hypertension [NA]
A study assessing the prevalence of hyperventilation syndrome in patients with pulmonary arterial hypertension, with trial status listed as …
-
FDA label_change · 2019-01-17FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for REVATIO (sildenafil citrate) submitted by Viatris Specialty LLC.
-
FDA label_change · 2019-01-17FDA Approved: REVATIO — Supplemental Application (Viatris Specialty LLC)
The FDA approved a supplemental application for Revatio (sildenafil citrate) submitted by Viatris Specialty LLC, resulting in changes to the…
-
CLINICAL_TRIALS trial_result · 2019-01-04Clinical Trial Update: Safety, Tolerability, and Pharmacokinetics of Oral Treprostinil in Pediatric PAH Patients Aged 7 to 17 Years [Phase 2]
Phase 2 trial evaluating safety, tolerability, and pharmacokinetics of oral treprostinil in pediatric pulmonary arterial hypertension patien…
-
FDA label_change · 2018-12-12FDA Approved: VELETRI — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for VELETRI (epoprostenol) from Actelion Pharmaceuticals US, Inc., resulting in a labeling update fo…
-
FDA approval · 2018-12-12FDA Approved: FLOLAN — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for FLOLAN (epoprostenol sodium) submitted by GlaxoSmithKline LLC.
-
FDA approval · 2018-12-06FDA Approved: ADEMPAS — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
FDA approved a supplemental application for ADEMPAS (riociguat) filed by Bayer HealthCare Pharmaceuticals Inc.
-
CLINICAL_TRIALS trial_result · 2018-12-03Clinical Trial Update: Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of MK-8892 in Participants With Pulmonary Arterial Hypertension (PAH) (MK-8892-005) [Phase 1]
Phase 1 trial assessing safety, tolerability, and pharmacokinetics of MK-8892 in participants with pulmonary arterial hypertension has compl…
-
FDA approval · 2018-11-30FDA Approved: LETAIRIS — Supplemental Application (Gilead Sciences, Inc.)
FDA approved a supplemental application for LETAIRIS (ambrisentan) filed by Gilead Sciences, Inc.
-
FDA approval · 2018-11-20FDA Approved: TREPROSTINIL — Supplemental Application (Sandoz Inc)
FDA approved a supplemental application for a generic Treprostinil water solution from Sandoz Inc.
-
CLINICAL_TRIALS trial_result · 2018-10-31Clinical Trial Update: Clinical Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument [Phase 3]
A Phase 3 trial evaluating macitentan in pulmonary arterial hypertension to psychometrically validate the PAH-SYMPACT instrument has complet…
-
FDA approval · 2018-10-25FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for TRACLEER (bosentan) submitted by Actelion Pharmaceuticals US, Inc., updating the product's label…
-
FDA approval · 2018-10-25FDA Approved: TRACLEER — Supplemental Application (Actelion Pharmaceuticals US, Inc.)
FDA approved a supplemental application for Tracleer (bosentan) submitted by Actelion Pharmaceuticals US, Inc.