Idiopathic Urticaria
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2024-08-15Clinical Trial Update: A Comparative Double-Blind, Double- Dummy Study of Desloratadine (DL) 5 MG Once Daily, Cetirizine 10 MG Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03735) [Phase 4]
A Phase 4 double-dummy trial compared desloratadine 5 mg daily, cetirizine 10 mg daily, and placebo in adults with chronic idiopathic urtica…
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CLINICAL_TRIALS trial_result · 2024-08-15Clinical Trial Update: Molecular Endotypes of Chronic Idiopathic Urticaria [Phase 4]
Phase 4 clinical trial update on molecular endotypes of chronic idiopathic urticaria; the study is currently active but not recruiting.
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CLINICAL_TRIALS trial_result · 2024-08-15Clinical Trial Update: A Comparative Double-blind, Double-dummy Study of Desloratadine (DL) 5 mg Once Daily, Cetirizine 10 mg Once Daily, and Placebo Once Daily in Patients With Chronic Idiopathic Urticaria (Study P03736) [Phase 4]
Phase 4 randomized, double-blind, double-dummy study comparing desloratadine 5 mg, cetirizine 10 mg, and placebo in chronic idiopathic urtic…
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FDA approval · 2024-07-11FDA Approved: XYZAL ALLERGY 24HR — Supplemental Application (Chattem, Inc.)
The FDA approved a supplemental application for XYZAL ALLERGY 24HR (levocetirizine dihydrochloride) filed by Chattem, Inc., related to a sup…
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FDA label_change · 2024-07-11FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)
The FDA approved a supplemental application to add Claritin Chewable Grape and Bubblegum (loratadine) as a chewable formulation from Bayer H…
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FDA approval · 2023-05-31FDA Approved: CLARITIN LIQUI-GELS — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application for Claritin LiQui-Gels (loratadine). The new liquid-filled gel capsule formulation expands the Clar…
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FDA approval · 2023-05-23FDA Approved: FEXOFENADINE HYDROCHLORIDE — Original Application (Aurohealth LLC)
FDA approves Aurohealth LLC's generic fexofenadine hydrochloride (oral) under Orig AP; indicated for allergic rhinitis and chronic idiopathi…
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FDA approval · 2023-05-01FDA Approved: DESLORATADINE — Supplemental Application (Virtus Pharmaceuticals, LLC)
FDA approved a supplemental application for desloratadine from Virtus Pharmaceuticals, LLC.
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FDA approval · 2023-03-17FDA Approved: XOLAIR — Supplemental Application (Genentech, Inc.)
FDA approved a supplemental application for XOLAIR (omalizumab) submitted by Genentech, Inc., representing an additional regulatory action f…
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FDA approval · 2022-12-08FDA Approved: LORATADINE ODT — Supplemental Application (Aurohealth LLC)
FDA approved a supplemental application for Loratadine ODT from Aurohealth LLC, updating the labeling for loratadine in an orally disintegra…
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FDA label_change · 2022-11-04FDA Approved: ALLERGY RELIEF — Supplemental Application (Publix Super Markets Inc)
FDA approved a supplemental application for Allergy Relief (fexofenadine hydrochloride) from Publix Super Markets Inc under ANDA 212971.
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FDA label_change · 2022-10-28FDA Approved: CHILDRENS XYZAL ALLERGY — Supplemental Application (Chattem, Inc.)
FDA approved a supplemental application to modify the labeling of CHILDRENS XYZAL ALLERGY (levocetirizine dihydrochloride) for pediatric use…
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CLINICAL_TRIALS trial_result · 2022-02-17Clinical Trial Update: How Desloratadine (Clarinex, Aerius) Affects Quality of Life in Patients With Chronic Idiopathic Urticaria (Have Had Hives for 6 Weeks or Longer)(Study P02988) [Phase 3]
Phase 3 trial evaluating desloratadine (Clarinex, Aerius) and its impact on quality of life in chronic idiopathic urticaria patients with hi…
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CLINICAL_TRIALS trial_result · 2022-02-17Clinical Trial Update: An Open-Label Study of the Effects of Desloratadine (Aerius.) Treatment on the Quality of Life of Patients With Chronic Idiopathic Urticaria (Study P02540) [Phase 4]
Phase 4 open-label study assessing desloratadine's effect on quality of life in chronic idiopathic urticaria patients; completed.
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CLINICAL_TRIALS trial_result · 2021-12-28Clinical Trial Update: A Study to Assess the Efficacy, Safety, and Tolerability of KPL-716 in Reducing Pruritus in Chronic Pruritic Diseases [Phase 2]
Phase 2 trial evaluating KPL-716 for reducing pruritus in chronic pruritic diseases completed; results have been posted.
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FDA approval · 2021-05-07FDA Approved: LORATADINE — Original Application (Camber Consumer Care Inc)
The FDA approved Camber Consumer Care Inc's loratadine product under an Original Application, marking the approval of this generic antihista…
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CLINICAL_TRIALS trial_result · 2021-04-20Clinical Trial Update: Role of Immunoglobulin E (IgE) Bearing Cells in Chronic Idiopathic Urticaria (CIU) [Phase 4]
Phase 4 trial update evaluating IgE-bearing cells in chronic idiopathic urticaria has completed with posted results.
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FDA approval · 2020-09-10FDA Approved: LORATADINE — Original Application (Advagen Pharma Limited)
FDA approved Advagen Pharma Limited's original ANDA for loratadine, a generic antihistamine indicated for allergic rhinitis and chronic idio…
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CLINICAL_TRIALS trial_result · 2020-04-09Clinical Trial Update: Mast Cell Activation Test in Allergic Disease
Completed clinical trial evaluating a mast cell activation test in allergic diseases; results posted in 2020.
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FDA approval · 2020-03-05FDA Approved: LORATADINE — Supplemental Application (Wal-Mart Stores, Inc)
FDA approved a supplemental application for loratadine submitted by Wal-Mart Stores, Inc., updating an already approved product under ANDA21…
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FDA approval · 2019-12-23FDA Approved: LORATADINE — Original Application (GRANULES USA, INC.)
FDA approved Granules USA, Inc.'s loratadine Original Application, granting a generic loratadine tablet product.
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FDA label_change · 2019-10-31FDA Approved: CAREONE ALLERGY RELIEF — Supplemental Application (American Sales Company)
FDA approved a supplemental application for CAREONE ALLERGY RELIEF containing fexofenadine HCl, submitted by American Sales Company.
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FDA approval · 2019-10-22FDA Approved: DESLORATADINE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approves a supplemental application for desloratadine submitted by Dr. Reddy's Laboratories Limited.
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FDA approval · 2019-10-22FDA Approved: DESLORATADINE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for desloratadine, a generic antihistamine used to treat allergy symptoms.
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FDA approval · 2019-10-21FDA Approved: GOOD SENSE LEVOCETIRIZINE — Supplemental Application (L. Perrigo Company)
FDA approved a supplemental application for Good Sense Levocetirizine (levocetirizine dihydrochloride) from L. Perrigo Company.