Idiopathic Urticaria
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-02-11FDA Approved: DESLORATADINE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for desloratadine from Dr. Reddy's Laboratories Limited.
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FDA approval · 2014-11-19FDA Approved: FEXOFENADINE HYDROCHLORIDE — Original Application (7-eleven)
FDA approved a generic version of fexofenadine hydrochloride (ANDA 202039) for allergic rhinitis and chronic urticaria, with 7-eleven as the…
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FDA approval · 2014-11-18FDA Approved: CHILDREN ALLERGY — Original Application (Walgreens)
FDA approved Walgreens' original application for a pediatric allergy product containing fexofenadine hydrochloride (Children Allergy).
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FDA approval · 2014-11-07FDA Approved: LORATADINE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental application for loratadine from Lannett Company, expanding the availability of this generic antihistamine.
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CLINICAL_TRIALS trial_result · 2014-11-03Clinical Trial Update: Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine Treatment [Phase 2]
A Phase 2 study evaluating the mode of action of omalizumab in chronic idiopathic urticaria patients who do not respond to antihistamines; r…
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FDA approval · 2014-09-09FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Vensun Pharmaceuticals, Inc.)
FDA approved the original application (ANDA) for levocetirizine dihydrochloride by Vensun Pharmaceuticals, Inc., providing a generic version…
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FDA approval · 2014-07-25FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application for Claritin Chewable Grape and Bubblegum containing loratadine, expanding the product line with a n…
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CLINICAL_TRIALS trial_result · 2014-06-18Clinical Trial Update: Efficacy and Safety of Omalizumab in Chronic Idiopathic Urticaria [Phase 3]
Phase 3 trial update discusses the efficacy and safety of omalizumab for chronic idiopathic urticaria.
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FDA approval · 2014-05-12FDA Approved: DESLORATADINE — Supplemental Application (Virtus Pharmaceuticals, LLC)
FDA approved a supplemental application for desloratadine from Virtus Pharmaceuticals, LLC.
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CLINICAL_TRIALS trial_result · 2014-04-15Clinical Trial Update: Prospective Double-blind Placebo-controlled Study of the Effect of Xolair (Omalizumab) in Chronic Urticaria Patients [Phase 2, Phase 3]
Prospective double-blind, placebo-controlled trial of omalizumab (Xolair) in chronic urticaria, spanning Phase 2 and Phase 3 cohorts.
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CLINICAL_TRIALS trial_result · 2013-12-12Clinical Trial Update: Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria [Phase 3]
A Phase 3 trial comparing the efficacy and safety of levocetirizine versus loratadine for chronic idiopathic urticaria has completed.
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FDA label_change · 2013-11-29FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved a supplemental application for levocetirizine dihydrochloride submitted by Glenmark Pharmaceuticals Inc., USA. This action …
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FDA approval · 2013-11-29FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA granted a supplemental approval for Levocetirizine dihydrochloride by Teva Pharmaceuticals USA, Inc. (generic) under an ANDA supplement.
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CLINICAL_TRIALS trial_result · 2013-11-26Clinical Trial Update: A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists [Phase 3]
Phase 3 safety study of Xolair (omalizumab) in adults with chronic idiopathic urticaria who remain symptomatic despite H1 antihistamines, H2…
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CLINICAL_TRIALS trial_result · 2013-10-18Clinical Trial Update: A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) Treatment [Phase 3]
A Phase 3 trial evaluating the efficacy and safety of omalizumab (Xolair) in chronic idiopathic urticaria and chronic spontaneous urticaria …
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FDA approval · 2013-09-17FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Original Application (Marlex Pharmaceuticals Inc)
FDA approved levocetirizine dihydrochloride under an original application for a generic antihistamine indicated for relief of symptoms of al…
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FDA approval · 2013-09-04FDA Approved: CAREONE ALLERGY RELIEF — Supplemental Application (American Sales Company)
FDA approved a supplemental application for CAREONE ALLERGY RELIEF (fexofenadine HCl) from American Sales Company; this pertains to the supp…
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CLINICAL_TRIALS trial_result · 2013-09-02Clinical Trial Update: A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1) [Phase 3]
Phase 3 trial evaluating the efficacy, duration of response, and safety of Xolair (omalizumab) in patients with chronic idiopathic urticaria…
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FDA approval · 2013-07-23FDA Approved: CLARINEX — Supplemental Application (Organon LLC)
FDA has approved a supplemental application for CLARINEX (desloratadine) submitted by Organon LLC.
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FDA approval · 2013-06-05FDA Approved: CLARITIN — Supplemental Application (Bayer HealthCare LLC)
The FDA approved a supplemental application for Claritin (loratadine) submitted by Bayer HealthCare LLC.
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FDA approval · 2013-02-05FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
The FDA approved Glenmark Pharmaceuticals Inc., USA's supplemental application for levocetirizine dihydrochloride, a generic antihistamine u…
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FDA approval · 2013-01-30FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Camber Pharmaceuticals' generic levocetirizine dihydrochloride.
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FDA approval · 2013-01-02FDA Approved: FEXOFENADINE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)
The U.S. FDA approved a supplemental application for fexofenadine hydrochloride from Dr. Reddy's Laboratories Limited.
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CLINICAL_TRIALS trial_result · 2012-12-03Clinical Trial Update: Bioequivalence Study of Levocetirizine Dihydrochloride Tablets 5 mg Under Fasting Condition [Phase 1]
Phase 1 bioequivalence study of Levocetirizine Dihydrochloride 5 mg tablets completed under fasting conditions.
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FDA approval · 2012-11-29FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Dr.Reddy's laboratories Ltd.)
FDA approved a supplemental application for levocetirizine dihydrochloride from Dr. Reddy's Laboratories Ltd., granting approval to an exist…