Pneumocystis Jirovecii Pneumonia
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FDA approval · 2020-07-28FDA Approved: BACTRIM — Supplemental Application (Sun Pharmaceutical Industries, Inc)
FDA approved a supplemental application for BACTRIM (sulfamethoxazole and trimethoprim) filed by Sun Pharmaceutical Industries, Inc. to upda…
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FDA approval · 2019-11-07FDA Approved: ATOVAQUONE — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)
FDA approved a supplemental application for atovaquone submitted by Chartwell Governmental & Specialty RX, LLC.
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FDA label_change · 2019-07-18FDA Approved: MEPRON — Supplemental Application (GlaxoSmithKline LLC)
The FDA approved a supplemental application for Mepron (atovaquone) from GlaxoSmithKline LLC, resulting in labeling changes.
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FDA approval · 2019-05-31FDA Approved: ATOVAQUONE ORAL SUSPENSION — Original Application (KVK-Tech, Inc.)
FDA approved a generic version of atovaquone oral suspension (KVK-Tech, Inc.) via Original Application (ANDA210510).
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FDA approval · 2019-04-24FDA Approved: PENTAMIDINE ISETHIONATE — Original Application (Seton Pharmaceuticals)
FDA approved pentamidine isethionate in an Original Application by Seton Pharmaceuticals. It is indicated for Pneumocystis jirovecii pneumon…
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FDA approval · 2019-02-22FDA Approved: MEPRON — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for Mepron (atovaquone) submitted by GlaxoSmithKline LLC. The action updates the drug's labeling/ind…
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FDA approval · 2018-11-21FDA Approved: ATOVAQUONE — Original Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved the original application for atovaquone as a generic drug, confirming its approved uses for Pneumocystis jirovecii pneumonia, p…
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FDA approval · 2018-10-11FDA Approved: ATOVAQUONE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' generic atovaquone under an original ANDA (ANDA 210692).
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FDA approval · 2017-10-16FDA Approved: DAPSONE — Original Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' generic version of dapsone (DAPSONE) through an original ANDA. The approval authorizes the sale …
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CLINICAL_TRIALS research · 2017-06-29Clinical Trial Update: Prospective Registration of Severe Pneumocystis Jiroveci Pneumonia Requiring ICU Admission
Prospective registration update for a trial on Pneumocystis jirovecii pneumonia requiring ICU care; current trial status is unknown.
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CLINICAL_TRIALS withdrawal · 2017-06-27Clinical Trial Update: Corticosteroids Therapy and Pneumocystis Jirovecii Pneumonia (PCP) [Phase 4]
A Phase 4 trial evaluating corticosteroid therapy for Pneumocystis jirovecii pneumonia has been withdrawn.
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FDA approval · 2016-12-01FDA Approved: DAPSONE — Original Application (ANI Pharmaceuticals, Inc.)
FDA approved ANI Pharmaceuticals' generic DAPSONE (dapsone) under an Original Application (ANDA206505).
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CLINICAL_TRIALS trial_result · 2016-06-30Clinical Trial Update: Intravenous Pentamidine for Pneumocystis Jirovecii Pneumonia
A completed clinical trial evaluating intravenous pentamidine for Pneumocystis jirovecii pneumonia in patients with hematologic malignancies…
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FDA approval · 2016-05-10FDA Approved: DAPSONE — Original Application (Chartwell RX, LLC)
The FDA approved the original ANDA for DAPSONE from Chartwell RX, LLC.
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CLINICAL_TRIALS trial_result · 2016-03-16Clinical Trial Update: Pulmonary Complications of HIV Infection Study (PACS)
The NHLBI study PACS (Pulmonary Complications of HIV Infection) has completed, investigating pulmonary complications of HIV/AIDS. It include…
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CLINICAL_TRIALS trial_result · 2015-12-11Clinical Trial Update: Pneumocystis Jerovici Pneumonia in Infants and Steroids [NA]
The clinical trial update indicates a completed study evaluating the use of adjunctive steroids for Pneumocystis jirovecii pneumonia in infa…
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FDA approval · 2015-07-09FDA Approved: DAPSONE — Supplemental Application (Pacific Pharma, Inc.)
The FDA approved a supplemental application for DAPSONE submitted by Pacific Pharma, Inc.
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FDA approval · 2015-06-04FDA Approved: MEPRON — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for Mepron (atovaquone) from GlaxoSmithKline LLC.
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FDA approval · 2014-12-21FDA Approved: SULFAMETHOXAZOLE AND TRIMETHOPRIM — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for sulfamethoxazole and trimethoprim from Amneal Pharmaceuticals of New York LLC. The approval cove…
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CLINICAL_TRIALS research · 2014-08-04Clinical Trial Update: A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy
A pharmacokinetic and pharmacogenetic study is being conducted in patients treated with sulfamethoxazole-trimethoprim for Pneumocystis jirov…
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FDA approval · 2014-03-18FDA Approved: ATOVAQUONE — Original Application (Amneal Pharmaceuticals LLC)
FDA approves Amneal Pharmaceuticals LLC's original ANDA for ATOVAQUONE, providing a generic option for Pneumocystis jirovecii pneumonia prop…
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FDA approval · 2013-10-03FDA Approved: DAPSONE — Supplemental Application (Pacific Pharma, Inc.)
The FDA approved a supplemental application for Dapsone from Pacific Pharma, Inc., resulting in changes to the product labeling under the su…
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CLINICAL_TRIALS trial_result · 2013-10-01Clinical Trial Update: A Study of Psychosocial and Behavioral Determinants of Differential Rates of Participant Compliance in CPCRA Protocols
This update reports results from an NIAID study examining psychosocial and behavioral factors that influence participant compliance across C…
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CLINICAL_TRIALS trial_result · 2013-03-07Clinical Trial Update: DB289 Versus TMP-SMX for the Treatment of Acute Pneumocystis Jiroveci Pneumonia (PCP) [Phase 3]
Phase 3 trial comparing DB289 to trimethoprim-sulfamethoxazole for acute Pneumocystis jirovecii pneumonia has been terminated.
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FDA approval · 2013-03-01FDA Approved: MEPRON — Supplemental Application (GlaxoSmithKline LLC)
FDA approved a supplemental application for MEPRON (atovaquone) from GlaxoSmithKline LLC.