Community-acquired Pneumonia
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2023-02-16Clinical Trial Update: Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia [Phase 3]
Phase 3 trial comparing nemonoxacin to levofloxacin in adults with community-acquired pneumonia has completed and results were posted in 202…
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CLINICAL_TRIALS trial_result · 2023-01-31Clinical Trial Update: Effect of Albumin Administration in Hypoalbuminemic Hospitalized Patients With Community-acquired Pneumonia. [Phase 3]
Phase 3 trial on albumin administration in hypoalbuminemic hospitalized patients with community-acquired pneumonia was terminated.
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FDA approval · 2023-01-27FDA Approved: ERTAPENEM — Supplemental Application (Eugia US LLC)
The FDA approved a supplemental application for ertapenem submitted by Eugia US LLC, authorizing changes to its approved labeling and/or ind…
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FDA approval · 2022-12-07FDA Approved: DOXYCYCLINE — Original Application (Par Health USA, LLC)
FDA approved a generic doxycycline product under an original new drug application by Par Health USA, LLC (ANDA216690).
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FDA approval · 2022-11-02FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (USAntibiotics, LLC)
FDA approved a supplemental application for Amoxicillin and Clavulanate Potassium submitted by USAntibiotics, LLC.
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FDA approval · 2022-10-31FDA Approved: LINEZOLID — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' LINEZOLID generic under an Original Abbreviated New Drug Application (ANDA 211813). The approval covers…
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FDA label_change · 2022-09-01FDA Approved: AMOXICILLIN AND CLAVULANATE POTASSIUM — Supplemental Application (Northstar RxLLC)
FDA approved a supplemental application for amoxicillin and clavulanate potassium submitted by Northstar RxLLC, resulting in updated labelin…
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FDA approval · 2022-02-08FDA Approved: ERTAPENEM — Supplemental Application (Apotex Corp)
FDA approved a supplemental application for Apotex Corp to market ertapenem sodium (ERTAPENEM) as a generic antibiotic.
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FDA approval · 2022-01-31FDA Approved: CLARITHROMYCIN — Original Application (Alembic Pharmaceuticals Inc.)
FDA approved Alembic Pharmaceuticals' generic clarithromycin under Original Application ANDA210459. This expands access to clarithromycin as…
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FDA approval · 2022-01-12FDA Approved: AZITHROMYCIN — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for AZITHROMYCIN submitted by Aurobindo Pharma Limited under an ANDA.
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CLINICAL_TRIALS trial_result · 2021-11-24Clinical Trial Update: Oral Nemonoxacin in Treating Elderly Patients With CAP [Phase 4]
Phase 4 trial update on oral nemonoxacin for treating community-acquired pneumonia in elderly patients has completed.
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CLINICAL_TRIALS trial_result · 2021-11-03Clinical Trial Update: Study to Evaluate the PK of PO Omadacycline in Adults With Community-Acquired Bacterial Pneumonia [Phase 1]
Phase 1 study assessing the pharmacokinetics of oral omadacycline in adults with community-acquired pneumonia has completed with posted resu…
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CLINICAL_TRIALS trial_result · 2021-10-25Clinical Trial Update: A Phase III Study to Evaluate the Efficacy and Safety of Intravenous Infusion of Nemonoxacin in Treating CAP [Phase 3]
Phase III trial evaluating intravenous nemonoxacin for community-acquired pneumonia has completed.
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CLINICAL_TRIALS trial_result · 2021-09-30Clinical Trial Update: Corticosteroids and Myocardial Injury in CAP (COLOSSEUM TRIAL) [Phase 3]
Phase 3 clinical trial update on the use of corticosteroids to reduce myocardial injury in community-acquired pneumonia (COLOSSEUM TRIAL).
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CLINICAL_TRIALS trial_result · 2021-09-24Clinical Trial Update: OPEP Devices in Acute Inpatient Treatment of Pneumonia [NA]
Clinical trial update for OPEP devices in acute inpatient treatment of community-acquired pneumonia; study terminated with results posted in…
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FDA approval · 2021-09-21FDA Approved: CEFTAROLINE FOSAMIL — Original Application (Apotex Corp.)
The FDA approved Apotex Corp.'s original application for ceftaroline fosamil, making a generic ceftaroline fosamil available in the United S…
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FDA approval · 2021-07-29FDA Approved: ZOSYN IN GALAXY CONTAINERS — Supplemental Application (Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.)
FDA approved a supplemental application to allow Zosyn (piperacillin/tazobactam) to be supplied in Galaxy containers, by Wyeth Pharmaceutica…
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CLINICAL_TRIALS trial_result · 2021-06-08Clinical Trial Update: Short-course Antimicrobial Therapy for Paediatric Respiratory Infections [Phase 4]
Phase 4 trial update on short-course antimicrobial therapy for paediatric respiratory infections, focusing on community-acquired pneumonia.
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FDA approval · 2021-02-19FDA Approved: CEFDINIR — Original Application (American Health Packaging)
FDA approves the original ANDA for cefdinir (CEFDINIR) by American Health Packaging, making a generic cefdinir product available.
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FDA approval · 2020-10-20FDA Approved: NUZYRA — Supplemental Application (Paratek Pharmaceuticals, Inc.)
FDA's supplemental application for NUZYRA (omadacycline) submitted by Paratek Pharmaceuticals, Inc., with the submission status indicated as…
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CLINICAL_TRIALS trial_result · 2020-09-11Clinical Trial Update: Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia [Phase 3]
Phase 3 pediatric trial update for ceftobiprole in community-acquired and hospital-acquired pneumonia; study completed with results posted.
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FDA approval · 2020-09-09FDA Approved: CEFTRIAXONE AND DEXTROSE — Supplemental Application (B. Braun Medical Inc.)
FDA approved a supplemental application for Ceftriaxone and Dextrose from B. Braun Medical, resulting in an updated/expanded approval for th…
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CLINICAL_TRIALS withdrawal · 2020-06-04Clinical Trial Update: EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA [Phase 3]
Phase 3 trial evaluating hydroxychloroquine plus azithromycin for prevention of COVID-19–related ARDS was withdrawn.
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FDA approval · 2020-06-03FDA Approved: AMOXICILLIN — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for amoxicillin submitted by Sandoz Inc.
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FDA approval · 2020-05-01FDA Approved: AZITHROMYCIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for AZITHROMYCIN from Lupin Pharmaceuticals, Inc., signaling an update to the product's regulatory a…