Pericarditis
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CLINICAL_TRIALS research · 2024-07-03Clinical Trial Update: Clinical Phenotypes in Pericarditis: IL-1RA Antibodies and suPAR Levels
Clinical trial evaluating phenotypes in pericarditis, examining IL-1RA antibodies and suPAR levels, currently recruiting participants.
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FDA approval · 2024-05-16FDA Approved: MITIGARE — Supplemental Application (Hikma Specialty USA Inc.)
FDA approved a supplemental application for Mitigare (colchicine) submitted by Hikma Specialty USA Inc. The action updates the product label…
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CLINICAL_TRIALS research · 2024-05-14Clinical Trial Update: Inflammation in Acute Cardiovascular Diseases - the CArdiovascular Inflammation Registry (CAIR)
This ClinicalTrials.gov listing describes the CAIR registry studying inflammation in acute cardiovascular diseases and indicates the trial i…
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FDA approval · 2024-04-29FDA Approved: COLCHICINE — Original Application (Granules Pharmaceutical Inc.)
FDA approved an Original Application for a generic colchicine product by Granules Pharmaceutical Inc., establishing a generic option for col…
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FDA approval · 2024-04-29FDA Approved: COLCHICINE — Original Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals’ generic colchicine under an original ANDA, authorizing its marketing as a generic product.
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FDA approval · 2024-04-29FDA Approved: COLCHICINE — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's original application for a generic colchicine product.
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CLINICAL_TRIALS trial_result · 2023-12-19Clinical Trial Update: Dexamethasone Compared to Non-steroidal Anti-inflammatory Drugs in the Treatment of Acute Pericarditis [Phase 4]
Phase 4 trial comparing dexamethasone to NSAIDs for acute pericarditis was terminated.
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FDA approval · 2023-06-16FDA Approved: LODOCO — Original Application (AGEPHA Pharma USA, LLC)
FDA approved LODOCO (colchicine tablets 0.5 mg) under an original NDA from AGEPHA Pharma USA, LLC.
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CLINICAL_TRIALS trial_result · 2023-04-10Clinical Trial Update: Therapeutic Approach in Colchicine-resistant Recurrent pEricarditis in Children [Phase 3]
Phase 3 trial update for a therapeutic approach in colchicine-resistant recurrent pericarditis in children; status not yet recruiting.
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CLINICAL_TRIALS trial_result · 2022-10-31Clinical Trial Update: Study to Evaluate the Efficacy and Safety of RPH-104 Treatment in Patients With Idiopathic Recurrent Pericarditis [Phase 2, Phase 3]
A clinical trial update for RPH-104 evaluating efficacy and safety in idiopathic recurrent pericarditis has completed Phase 2 and Phase 3. N…
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FDA approval · 2022-03-10FDA Approved: COLCHICINE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved an original ANDA for colchicine from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals Inc.), providing a generic version of…
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FDA approval · 2021-08-13FDA Approved: COLCHICINE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' original ANDA for colchicine, authorizing a generic version of the drug.
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FDA approval · 2021-08-12FDA Approved: COLCHICINE — Original Application (Par Health USA, LLC)
FDA approved the original application for colchicine (generic) from Par Health USA, LLC.
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CLINICAL_TRIALS trial_result · 2021-07-13Clinical Trial Update: Study to Assess the Efficacy and Safety of Rilonacept Treatment in Participants With Recurrent Pericarditis [Phase 3]
Phase 3 trial assessing rilonacept for recurrent pericarditis completed with results posted in 2021.
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EMA safety_alert · 2021-07-09Comirnaty and Spikevax: possible link to very rare cases of myocarditis and pericarditis
EMA states possible link between Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) vaccines and very rare cases of myocarditis and pericard…
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CLINICAL_TRIALS trial_result · 2021-05-27Clinical Trial Update: A Pilot Study of KPL-914 in Recurrent Pericarditis [Phase 2]
Phase 2 pilot study of KPL-914 in recurrent pericarditis completed; results posted in 2021.
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CLINICAL_TRIALS trial_result · 2021-02-23Clinical Trial Update: Treatment of Acute Pericarditis With Anakinra [Phase 2]
Phase 2 trial of anakinra for acute pericarditis has been terminated with results posted.
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FDA approval · 2020-03-30FDA Approved: COLCHICINE — Supplemental Application (Dr.Reddys Laboratories, Inc.)
FDA approved a supplemental application for Colchicine submitted by Dr. Reddy's Laboratories, Inc.
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FDA approval · 2019-11-14FDA Approved: COLCHICINE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for COLCHICINE from Zydus Lifesciences Limited. This indicates a supplemental approval for this gene…
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FDA approval · 2019-09-16FDA Approved: COLCHICINE — Original Application (Mylan Pharmaceuticals Inc.)
The FDA approved a generic colchicine product from Mylan Pharmaceuticals Inc. under an original ANDA (ANDA209470).
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FDA approval · 2019-02-08FDA Approved: COLCHICINE — Original Application (Ascend Laboratories, LLC)
FDA approved Ascend Laboratories, LLC's original ANDA application for Colchicine, making a generic colchicine product available in the U.S.
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FDA approval · 2018-11-29FDA Approved: COLCHICINE — Original Application (Par Health USA, LLC)
The FDA approved an original ANDA for colchicine from Par Health USA, LLC, enabling the marketing of a generic colchicine product. This repr…
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FDA approval · 2018-11-16FDA Approved: MITIGARE — Supplemental Application (Hikma Specialty USA Inc.)
The FDA approved a supplemental application for MITIGARE (colchicine) filed by Hikma Specialty USA Inc.
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CLINICAL_TRIALS research · 2018-05-25Clinical Trial Update: A Survey of Hospitalizations in Cardiology Units in Sub-Saharan Africa
This clinical trial update describes a survey of hospitalizations in cardiology units across Sub-Saharan Africa. The study covers various ca…
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CLINICAL_TRIALS trial_result · 2017-08-17Clinical Trial Update: Management of Pericarditis in Children.
Clinical trial update on the management of pericarditis in children. Sponsor: Assiut University; trial status is UNKNOWN.