Patent Ductus Arteriosus
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CLINICAL_TRIALS trial_result · 2025-01-08Clinical Trial Update: Comparative Analysis of Isolated Venous, Isolated Arterial, and Standard Access for Transcatheter Closure of Patent Ductus Arteriosus (PDA) [NA]
A completed clinical trial comparing isolated venous, isolated arterial, and standard access for transcatheter closure of patent ductus arte…
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FDA approval · 2024-11-21FDA Approved: INDOMETHACIN — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for indomethacin submitted by Chartwell RX, LLC. This action represents an approved supplement t…
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FDA approval · 2024-11-21FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approves a supplemental application for Indomethacin from Amneal Pharmaceuticals LLC (ANDA 091549), authorizing a supplemental change to…
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CLINICAL_TRIALS research · 2024-10-22Clinical Trial Update: Outcome of Transcatheter Closure of Patent Ductus Arteriosus in Pediatric Cardiology Unit in 3 Years Duration [NA]
This clinical trial entry describes a plan to evaluate transcatheter closure of patent ductus arteriosus in pediatric patients over a three-…
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CLINICAL_TRIALS trial_result · 2024-10-18Clinical Trial Update: Paracetamol And Ibuprofen/Indomethacin in Closing Patent Ductus Arteriosus [Phase 1]
This clinical trial update notes the termination of a Phase 1 study evaluating paracetamol in combination with ibuprofen or indomethacin for…
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CLINICAL_TRIALS research · 2024-10-15Clinical Trial Update: Study of Thoracic Ultrasound As a Response to the Closure of Hemodynamically Significant Patent Ductus Arteriosus in Premature Infants
A recruiting clinical study evaluating thoracic ultrasound as a monitoring or response tool after closure of hemodynamically significant pat…
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CLINICAL_TRIALS trial_result · 2024-06-21Clinical Trial Update: Canadian National PDA Treatment Study
A clinical trial in Canada addressing PDA treatment has completed.
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CLINICAL_TRIALS trial_result · 2024-06-21Clinical Trial Update: Selective Early Medical Treatment of Patent Ductus Arteriosus in Extremely Low Gestational Age Infants: A Pilot RCT [Phase 3]
Phase 3 randomized trial evaluating selective early medical treatment of patent ductus arteriosus in extremely preterm infants; recruitment …
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CLINICAL_TRIALS trial_result · 2024-02-13Clinical Trial Update: Assessment of Therapeutic Effect of Rectal Vs. Intravenous Paracetamol in The Treatment of Patent Ductus Arteriosus (PDA) in Neonates [Phase 1, Phase 2]
A clinical trial update comparing rectal versus intravenous paracetamol for treating Patent Ductus Arteriosus in neonates, currently in Phas…
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CLINICAL_TRIALS trial_result · 2024-02-07Clinical Trial Update: Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants [NA]
A terminated clinical trial evaluating percutaneous intervention versus observational management for patent ductus arteriosus in low-weight …
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CLINICAL_TRIALS trial_result · 2023-12-01Clinical Trial Update: Comparision Between Paracetamol and Ibuprofen in Closure of Patent Ductus Arteriosus [Phase 2]
Phase 2 clinical trial comparing paracetamol and ibuprofen for closure of patent ductus arteriosus.
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CLINICAL_TRIALS trial_result · 2023-10-30Clinical Trial Update: PAIR (Paracetamol and Ibuprofen Research) Pilot Trial [Phase 2, Phase 3]
A pilot trial (Phase 2/Phase 3) investigating paracetamol and ibuprofen for patent ductus arteriosus is in early/unknown status.
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FDA approval · 2023-09-07FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Indomethacin submitted by Amneal Pharmaceuticals LLC.
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CLINICAL_TRIALS trial_result · 2023-02-28Clinical Trial Update: Oral Ibuprofen Versus Placebo in Treatment of Patent Ductus Arteriosus (PDA)in Preterm Infants [Phase 2]
Phase 2 trial comparing oral ibuprofen to placebo for treatment of patent ductus arteriosus in preterm infants has completed.
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CLINICAL_TRIALS trial_result · 2022-09-16Clinical Trial Update: Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants [Phase 2, Phase 3]
Phase 2/3 trial investigating fenoldopam to prevent renal dysfunction in indomethacin-treated preterm infants was terminated; results posted…
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CLINICAL_TRIALS trial_result · 2021-05-11Clinical Trial Update: Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus [Phase 2]
Phase 2 randomized trial evaluating safety and efficacy of acetaminophen with ibuprofen for closing the ductus arteriosus in preterm infants…
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FDA approval · 2021-04-28FDA Approved: INDOCIN — Supplemental Application (Zyla Life Sciences US LLC)
The FDA has approved a supplemental application for INDOCIN (indomethacin) by Zyla Life Sciences US LLC.
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FDA approval · 2021-04-28FDA Approved: INDOMETHACIN — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal Pharmaceuticals LLC's supplemental application for Indomethacin, approving a generic Indomethacin product.
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FDA approval · 2021-04-28FDA Approved: INDOMETHACIN — Supplemental Application (XLCare Pharmaceuticals Inc.)
FDA approved a supplemental application for Indomethacin from XLCare Pharmaceuticals Inc. This approval updates the drug's existing FDA appr…
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FDA approval · 2021-04-26FDA Approved: INDOMETHACIN — Supplemental Application (XLCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for Indomethacin submitted by XLCare Pharmaceuticals Inc. under ANDA 091240.
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CLINICAL_TRIALS trial_result · 2020-10-05Clinical Trial Update: AMPLATZER Duct Occluder II Additional Sizes [NA]
Clinical trial update reporting results for AMPLATZER Duct Occluder II with additional sizes for closing patent ductus arteriosus. The study…
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CLINICAL_TRIALS trial_result · 2019-12-03Clinical Trial Update: Acetaminophen vs Indomethacin in Treating hsPDA [Phase 3]
A Phase 3 trial comparing acetaminophen versus indomethacin for treating patent ductus arteriosus was terminated.
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FDA approval · 2019-08-14FDA Approved: NEOPROFEN — Supplemental Application (Recordati Rare Diseases Inc.)
The FDA approved a supplemental application for NEOPROFEN (ibuprofen lysine) from Recordati Rare Diseases Inc., expanding its approved use o…
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FDA approval · 2019-07-18FDA Approved: PROSTIN VR PEDIATRIC — Supplemental Application (Pharmacia & Upjohn Company LLC)
The FDA approved a supplemental application for PROSTIN VR PEDIATRIC (alprostadil) submitted by Pharmacia & Upjohn Company LLC. The action p…
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CLINICAL_TRIALS trial_result · 2019-07-12Clinical Trial Update: Paracetamol in Patent Ductus Arteriosus [Phase 2]
Phase 2 clinical trial update for paracetamol in treating patent ductus arteriosus has completed.