Urticaria
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Sign up freeTop drugs studied for this disease
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FDA approval · 2020-10-30FDA Approved: LORATADINE — Original Application (Tenshi Kaizen Pvt Ltd)
FDA approved an original generic application for loratadine (Tenshi Kaizen Pvt Ltd).
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CLINICAL_TRIALS trial_result · 2020-09-25Clinical Trial Update: A Study to Evaluate the Long-term Safety and Efficacy of Fenebrutinib in Participants Previously Enrolled in a Fenebrutinib Chronic Spontaneous Urticaria (CSU) Study [Phase 2]
A Phase 2 trial assessing long-term safety and efficacy of fenebrutinib in participants previously enrolled in a CSU study has been terminat…
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FDA approval · 2020-09-21FDA Approved: ALL DAY ALLERGY — Original Application (WALMART INC. (see also Equate))
FDA approved Walmart's All Day Allergy cetirizine hydrochloride as an original generic application (ANDA 213105), enabling a Walmart/Equate …
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FDA approval · 2020-09-18FDA Approved: LORATADINE — Original Application (Tenshi Kaizen Pvt Ltd)
FDA approved Tenshi Kaizen Pvt Ltd's Loratadine as an original generic application. The product is indicated for allergic rhinitis and urtic…
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FDA approval · 2020-09-11FDA Approved: CETIRIZINE HYDROCHLORIDE — Original Application (Aurohealth LLC)
FDA approved the original generic application for cetirizine hydrochloride to be marketed by Aurohealth LLC.
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FDA approval · 2020-08-07FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application to add Claritin Chewable Grape and Bubblegum (loratadine) as a new chewable dosage form. This expand…
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FDA approval · 2020-03-17FDA Approved: DIPHENHYDRAMINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)
FDA approved a supplemental application for Diphenhydramine hydrochloride from PAI Pharma, indicating an approved modification to an existin…
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FDA approval · 2020-03-03FDA Approved: ALLERGY RELIEF — Supplemental Application (Ohm Laboratories Inc.)
FDA approved a supplemental application for Allergy Relief (loratadine) from Ohm Laboratories Inc.
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FDA approval · 2020-03-03FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)
FDA approved a supplemental application for cetirizine hydrochloride from Padagis Israel Pharmaceuticals Ltd. It is a generic antihistamine …
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FDA approval · 2020-03-03FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Bionpharma Inc.)
The FDA approved a supplemental application for cetirizine hydrochloride by Bionpharma Inc., under ANDA078488, granting regulatory approval …
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FDA label_change · 2020-03-03FDA Approved: CHILDREN ALLERGY — Supplemental Application (Walgreens)
FDA approved a supplemental application for a pediatric allergy indication using fexofenadine hydrochloride (Children's Allergy), expanding …
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FDA label_change · 2020-03-03FDA Approved: CETIRIZINE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approves a supplemental application for cetirizine hydrochloride from Sun Pharmaceutical to update labeling under an ANDA.
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FDA approval · 2020-02-24FDA Approved: ALLERGY RELIEF — Original Application (Publix Super Markets Inc)
FDA approved Publix Super Markets Inc's original application for a generic fexofenadine hydrochloride allergy relief product (brand name All…
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FDA approval · 2019-12-31FDA Approved: GOOD SENSE LEVOCETIRIZINE — Supplemental Application (L. Perrigo Company)
FDA approved a supplemental application for Good Sense Levocetirizine (levocetirizine dihydrochloride) from L. Perrigo Company.
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FDA approval · 2019-12-13FDA Approved: CETIRIZINE HCL — Supplemental Application (AMERISOURCE BERGEN)
FDA approved a supplemental application for Cetirizine HCl submitted by AmerisourceBergen, updating the NDA to reflect the approved suppleme…
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CLINICAL_TRIALS trial_result · 2019-11-27Clinical Trial Update: Clinical Trial Comparing JDP-205 to Diphenhydramine Injection for the Treatment of Acute Urticaria [Phase 3]
Phase 3 trial comparing JDP-205 to diphenhydramine injection for acute urticaria has completed with posted results.
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FDA approval · 2019-11-07FDA Approved: CLARITIN CHEWABLE GRAPE AND BUBBLEGUM — Supplemental Application (Bayer HealthCare LLC.)
The FDA approved a supplemental application to add a chewable grape and bubblegum formulation of Claritin (loratadine) from Bayer HealthCare…
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FDA approval · 2019-10-25FDA Approved: ALLERGY RELIEF 24HR — Supplemental Application (VELOCITY PHARMA LLC)
FDA approved a supplemental application for ALLERGY RELIEF 24HR (levocetirizine dihydrochloride) by Velocity Pharma LLC.
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CLINICAL_TRIALS trial_result · 2019-10-04Clinical Trial Update: Safety Study of Levocetirizine and Fexofenadine [Phase 4]
Phase 4 safety study investigating levocetirizine and fexofenadine in pruritus and chronic urticaria completed with posted results.
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CLINICAL_TRIALS trial_result · 2019-09-17Clinical Trial Update: Chronic Urticaria - Long Term Assessment of Effects of Rupatadine [Phase 3]
Phase 3 long-term assessment of rupatadine in chronic urticaria; study terminated.
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FDA approval · 2019-09-13FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)
The FDA approved a supplemental application for levocetirizine dihydrochloride from Macleods Pharmaceuticals Limited under ANDA205564.
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FDA approval · 2019-08-29FDA Approved: LEVOCETIRIZINE DIHYDROCHLORIDE — Supplemental Application (Vensun Pharmaceuticals, Inc.)
The FDA approved a supplemental application for levocetirizine dihydrochloride from Vensun Pharmaceuticals, Inc., finalizing an update to an…
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FDA label_change · 2019-08-07FDA Approved: ZYRTEC HIVES — Supplemental Application (Kenvue Brands LLC)
The FDA approved a supplemental indication to expand ZYRTEC HIVES (cetirizine hydrochloride) for the treatment of urticaria (hives). The pro…
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CLINICAL_TRIALS trial_result · 2019-06-24Clinical Trial Update: A Trial to Evaluate the Effect of Vitamin D Supplementation in Patients With Chronic Urticaria [Phase 4]
Phase 4 clinical trial evaluating the effect of vitamin D supplementation in patients with chronic urticaria and vitamin D deficiency; statu…
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CLINICAL_TRIALS trial_result · 2019-06-21Clinical Trial Update: Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of GSK2646264 [Phase 1]
Phase 1 trial evaluating safety, tolerability, pharmacodynamics and pharmacokinetics of GSK2646264 in urticaria completed with results poste…