Drugs / Cetirizine
Cetirizine
also known as
AC-170 · Zyrtec · cetirizine hydrochloride · Cetirizine HCl · Cetirizine dihydrochloride · AFH-002 · Allacan · Allertek · +27 more
Other / unclassified targets HRH1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed atopic conjunctivitis 1 milestone | |||||
| Filed | China (NMPA) | ZERVIATE | atopic conjunctivitis | 2023-04-14 | “New Drug Application (NDA) for approval to commercialize ZERVIATE® (cetirizine ophthalmic solution), 0.24%, submitted in China by its exclusive Chinese partner” nicox.com ↗ “submitted in April 2023 a New Drug Application for approval to commercialize ZERVIATE® (cetirizine ophthalmic solution), 0.24% in China” nicox.com ↗ “has submitted a New Drug Application (NDA) for approval to commercialize ZERVIATE® (cetirizine ophthalmic solution), 0.24%, in China” nicox.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | CHILDREN'S ZYRTEC ALLERGY | — | 2007-11-16 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | ZYRTEC | — | 1998-05-15 – 2002-10-21 | fda.gov ↗ |
| Approved | US (FDA) | ZYRTEC HIVES | — | 1995-12-08 | fda.gov ↗ |
Trials 58
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03167216 | Aug 2017 → Apr 2022 | chronic prostatitis | Northwestern University | Completed | No outcome recorded |
| Phase 19 trials | ||||||
| Phase 1 | NCT07853053 | Jan 2027 → Dec 2029 expected | urinary bladder cancer | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT02173249 | Jun → Aug 2014 | — | Aciex Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01495338 | Dec 2011 | — | Aciex Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02447393 | Mar → Apr 2008 | dermatitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00863902 | Aug → Sep 2006 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00864279 | Aug → Sep 2006 | — | Actavis Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00881127 | Jul 2005 | allergic disease | Sandoz | Completed | No outcome recorded |
| Phase 1 | NCT00649857 | Nov → Dec 2002 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00650065 | Nov → Dec 2002 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06126991 | Jan → Dec 2024 | — | Ruijin Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT05476679 | Sep 2022 → Jun 2023 | — | Raziel Therapeutics Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT02865018 | Apr 2014 → Feb 2016 | neuromyelitis optica | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 27 trials · 1 met primary | ||||||
| Phase 2 | NCT05922358 | Sep 2023 → Sep 2025 overdue | digestive system neoplasm | Fujian Cancer Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04179461 | Mar 2018 → Oct 2019 | childhood onset asthma | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT01651871 | Jul → Nov 2012 | seasonal allergic rhinitis | Shionogi | Completed | No outcome recorded |
| Phase 2 | NCT01241214 | Nov 2010 → Feb 2011 | seasonal allergic rhinitis | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01103050 | Mar → Jul 2010 | allergic rhinitis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT00533637 | Sep → Dec 2007 | allergic rhinitis | Biolipox AB | Completed | No outcome recorded |
| Phase 2 | NCT00291642 | Jan → Apr 2006 | seasonal allergic rhinitis | UCB Pharma | Completed | Met primary |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04481412 | Jul 2020 → Nov 2021 | androgenetic alopecia | Cairo University | Completed | No outcome recorded |
| Phase 2/3 | NCT01332188 | Apr → Jun 2011 | atopic conjunctivitis | Aciex Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 319 trials · 2 met primary | ||||||
| Phase 3 | NCT07472413 | Nov 2026 → Jul 2028 expected | multiple sclerosis | University of Miami | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06819774 | Apr 2024 → Aug 2025 overdue | urticaria | Shandong New Time Pharmaceutical Co., LTD | Recruiting | No outcome recorded |
| Phase 3 | NCT05946551 | Mar → Jun 2024 | COVID-19 | Emory University | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04237090 | Feb → Aug 2020 | breast cancer, cervical cancer, endometrial cancer, esophageal cancer +3 | Ciusss de L'Est de l'Île de Montréal | Completed | Met primary |
| Phase 3 | NCT02935699 | Mar 2017 → Apr 2018 | urticaria | JDP Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT02756624 | Apr → Aug 2016 | — | Nicox Ophthalmics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02132169 | May → Oct 2014 | eye allergy | Aciex Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02023164 | Jul 2013 → Dec 2014 | urticaria | JDP Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01881113 | Jun → Oct 2013 | conjunctivitis | Aciex Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01685242 | Sep → Nov 2012 | eye allergy | Aciex Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01551056 | Mar → Jun 2012 | conjunctivitis | Aciex Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00490204 | Jul → Oct 2007 | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00257582 | Aug 2005 → ? | — | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00257595 | Aug 2005 → ? | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00257569 | Aug 2005 → ? | atopic eczema | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00253058 | Jul 2005 → ? | perennial allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00794378 | Nov 2004 | allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00794794 | Nov 2004 | allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 3 | NCT00639587 | Aug 2002 → Mar 2003 | perennial allergic rhinitis | UCB Pharma | Completed | No outcome recorded |
| Phase 412 trials · 1 met primary · 1 missed | ||||||
| Phase 4 | NCT04836806 | Aug 2021 → Jul 2022 | COVID-19 | Emory University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT05095311 | May 2021 → Apr 2022 | — | Indiana University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04293822 | Jun → Nov 2020 | androgenetic alopecia | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT03340740 | May 2018 → Aug 2021 | allergic rhinitis, asthma | New York City Health and Hospitals Corporation | Completed | No outcome recorded |
| Phase 4 | NCT03192488 | Aug 2017 → Jun 2018 | altitude sickness | Indiana University | Completed | Met primary |
| Phase 4 | NCT02543346 | Oct 2015 → Feb 2016 | allergic rhinitis | Queen's University | Completed | No outcome recorded |
| Phase 4 | NCT01916226 | Aug → Oct 2013 | allergic rhinitis | GlaxoSmithKline | Completed | Missed primary |
| Phase 4 | NCT01781507 | Jun → Dec 2011 | allergic rhinitis, asthma | California Allergy and Asthma Medical Group, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00794599 | Dec 2002 → Aug 2003 | perennial allergic rhinitis, seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00794846 | Dec 2002 → May 2003 | perennial allergic rhinitis, seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00794495 | Dec 2002 → Jul 2003 | perennial allergic rhinitis, seasonal allergic rhinitis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT02932774 | Mar → Jul 2001 | seasonal allergic rhinitis | Johnson & Johnson Consumer and Personal Products Worldwide | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT06890260 | Apr 2025 → Jun 2027 expected | allergic rhinitis | Pengfei Qiu | Recruiting | No outcome recorded |
| — | NCT04935515 | Apr → May 2021 | COVID-19 | Manimarane Arjunan, MD,DM (Cardiology) | Completed | No outcome recorded |
| — | NCT01318681 | Jan 2011 → Mar 2012 | seasonal allergic rhinitis | Maastricht University Medical Center | Completed | No outcome recorded |
| — | NCT00474890 | Jun → Dec 2007 | IgE responsiveness, atopic, rhinitis | Fraunhofer-Institute of Toxicology and Experimental Medicine | Completed | No outcome recorded |
| — | NCT00334698 | Jul → Sep 2006 | seasonal allergic rhinitis | Fraunhofer-Institute of Toxicology and Experimental Medicine | Completed | No outcome recorded |
| Comparator or background therapy49 trials | ||||||
| Phase 1 | NCT04071821 Comparator | May → Jul 2025 | allergic disease | Seattle Gummy Company | Unknown | No outcome recorded |
| Phase 1 | NCT04568902 Background | Sep 2020 → Oct 2025 | breast cancer | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02665754 Background | Jul 2016 → Dec 2019 | allergic rhinitis | Gachon University Gil Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT02535416 Background | Sep 2015 → Aug 2016 | — | Arrowhead Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT01981499 Background | Jan → Apr 2014 | migraine disorder | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT01622283 Comparator | May → Jun 2012 | allergic rhinitis | GlaxoSmithKline | Completed | Met primary |
| Phase 1 | NCT02024152 Comparator | Mar → Jul 2011 | urticaria | JDP Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01068223 Comparator | Feb → May 2010 | urticaria | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00881634 Comparator | Jun → Jul 2005 | allergic disease | Sandoz | Completed | No outcome recorded |
| Phase 1/2 | NCT04990388 Background | Oct 2021 → Mar 2023 | glycogen storage disease III | Ultragenyx Pharmaceutical Inc | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04189588 Comparator | Mar → Nov 2020 | — | TerSera Therapeutics LLC | Completed | No outcome recorded |
| Phase 2 | NCT02738008 Background | Mar → Dec 2016 | hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | No outcome recorded |
| Phase 2 | NCT02604212 Background | Nov 2015 → Dec 2016 | hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | Met primary |
| Phase 2 | NCT02604199 Background | Sep 2015 → Jan 2017 | chronic hepatitis B virus infection | Arrowhead Pharmaceuticals | Terminated | Met primary |
| Phase 2 | NCT01748344 Comparator | Nov 2012 → Feb 2014 | seasonal allergic rhinitis | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01902836 Background | Aug 2011 → Dec 2012 | atopic eczema | National Polytechnic Institute, Mexico | Completed | No outcome recorded |
| Phase 2 | NCT01134328 Comparator | May → Jul 2010 | conjunctivitis | Aciex Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00972504 Comparator | Jun → Aug 2009 | seasonal allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00866788 Background | Mar 2009 → Jan 2010 | chronic idiopathic urticaria | Genentech, Inc. | Completed | Met primary |
| Phase 2 | NCT00851344 Comparator | Sep → Nov 2008 | seasonal allergic rhinitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00420082 Comparator | Oct → Dec 2006 | seasonal allergic rhinitis | Faes Farma, S.A. | Completed | No outcome recorded |
| Phase 3 | NCT06754410 Comparator | Mar 2021 → Mar 2024 | ureterolithiasis | South Valley University | Completed | No outcome recorded |
| Phase 3 | NCT04175834 Comparator | Feb 2020 → May 2022 | multiple sclerosis | Providence Health & Services | Completed | No outcome recorded |
| Phase 3 | NCT04612803 Comparator | Feb 2020 → Aug 2026 | functional diarrhea, irritable bowel syndrome, urticaria | University of Cincinnati | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT02613910 Background | Dec 2015 → Mar 2016 | pemphigus | GlaxoSmithKline | Terminated | No outcome recorded |
| Phase 3 | NCT01484119 Comparator | Dec 2011 → Feb 2012 | seasonal allergic rhinitis | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT00375713 Comparator | Oct 2005 → May 2006 | dermatitis | UCB Pharma | Completed | No outcome recorded |
| Phase 3 | NCT00504933 Comparator | May → Nov 2005 | seasonal allergic rhinitis | Faes Farma, S.A. | Completed | Met primary |
| Phase 3 | NCT01127620 Comparator | May 2004 → Mar 2006 | perennial allergic rhinitis | Faes Farma, S.A. | Completed | Missed primary |
| Phase 3 | NCT00974571 Comparator | Nov 2001 → May 2002 | perennial allergic rhinitis | Organon and Co | Completed | Missed primary |
| Phase 4 | NCT06118710 Background | Jun 2024 → Jun 2027 expected | cancer | Erasmus Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT06019728 Background | Nov 2023 → Oct 2024 | Fabry disease | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT03047278 Comparator | Nov 2015 → May 2018 | diabetic neuropathy, neuropathy, painful, type 2 diabetes mellitus | Natalia Valadares de Moraes | Completed | No outcome recorded |
| Phase 4 | NCT02205489 Background | Oct 2014 → Apr 2016 | relapsing-remitting multiple sclerosis | Genzyme, a Sanofi Company | Completed | No outcome recorded |
| Phase 4 | NCT01825655 Comparator | Sep 2014 → Nov 2017 | — | Virginia Commonwealth University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT01985789 Comparator | Nov 2013 → May 2014 | asthma | Don Cockcroft | Completed | No outcome recorded |
| Phase 4 | NCT01940393 Comparator | Aug → Dec 2013 | urticaria | Grupo de Alergología Clínica y Experimental | Completed | No outcome recorded |
| Phase 4 | NCT00826943 Comparator | Jan → May 2009 | allergic rhinitis | Vanderbilt University | Completed | No outcome recorded |
| Phase 4 | NCT00561717 Comparator | Oct → Dec 2007 | seasonal allergic rhinitis | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT00488176 Comparator | Apr 2007 → Nov 2013 | seasonal allergic rhinitis | Medical University of Lodz | Unknown | No outcome recorded |
| Phase 4 | NCT00779116 Comparator | Sep → Oct 2005 | allergic disease | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00780403 Comparator | Aug → Oct 2005 | allergic disease | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00240032 Comparator | Oct 2004 → Jun 2006 | multiple sclerosis | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00751218 Comparator | May 2004 → May 2005 | chronic idiopathic urticaria | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT00751166 Comparator | Mar 2004 → May 2005 | urticaria | Organon and Co | Terminated | No outcome recorded |
| — | NCT07236372 Comparator | Nov 2025 → Mar 2027 expected | urticaria | University of Phayao | Recruiting | No outcome recorded |
| — | NCT04706559 Background | Jan → Sep 2021 | atopic eczema | B.P. Koirala Institute of Health Sciences | Completed | No outcome recorded |
| — | NCT02451579 Comparator | Feb 2015 → Dec 2016 | actinic keratosis | Goldman, Butterwick, Fitzpatrick and Groff | Completed | No outcome recorded |
| — | NCT00610584 Comparator | Apr 2008 → Apr 2011 | seasonal allergic rhinitis | Charite University, Berlin, Germany | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2024-09-18 | NicOx Inc. | Regulatory Nicox Announces Approval of ZERVIATE in China nicox.com ↗
Nicox SA (Euronext Growth Paris: FR0013018124, ALCOX), an international ophthalmology company, today announced that its exclusive Chinese partner, Ocumension Therapeutics, has received approval of the New Drug Application (NDA) to commercialize ZERVIATE® (cetirizine ophthalmic solution), 0.24% in China for ocular itching associated with allergic conjunctivitis. |
| 2023-04-28 | NicOx Inc. | Regulatory Nicox’s Partner Ocumension Therapeutics Receives Priority Review Status for ZERVIATE New Drug Application in China nicox.com ↗
Nicox’s partner, Ocumension Therapeutics, announced on April 26, 2023, that they had received Priority Review Status for the New Drug Application for ZERVIATE in China |
| 2023-04-19 | NicOx Inc. | Regulatory Nicox Provides First Quarter 2023 Financial and Business Highlights nicox.com ↗ |
| 2023-04-14 | NicOx Inc. | Regulatory Additional Future Royalty Revenue Stream for Nicox from 2024 following New Drug Application Submission for ZERVIATE in China nicox.com ↗
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its exclusive Chinese partner, Ocumension Therapeutics, has submitted a New Drug Application (NDA) for approval to commercialize ZERVIATE® (cetirizine ophthalmic solution), 0.24%, in China, for ocular itching associated with allergic conjunctivitis. |
| 2022-03-01 | NicOx Inc. | Results Nicox’s Partner Ocumension Obtains Positive Phase 3 Clinical Trial Results for ZERVIATE® in China nicox.com ↗
ZERVIATE was found to be non-inferior to emedastine difumarate in the primary efficacy endpoint of change from baseline in the itching score in the 24 hours prior to the Day 14 visit. |
| 2021-03-05 | TerSera Therapeutics LLC | Results TerSera® Presents Data on Cetirizine HCl Injection (QUZYTTIR®) in the Prevention of Hypersensitivity Infusion Reactions in Patients with Breast Cancer and Other Malignancies tersera.com ↗
Time for discharge was 24 minutes less with IV cetirizine versus IV diphenhydramine. |
| 2013-09-10 | Perrigo Company | Regulatory Perrigo Company Announces FDA Final Approval For The Store Brand Equivalent To Children's Zyrtec® Allergy Syrup, 1 mg/mL perrigo.com ↗
Perrigo Company (NYSE: PRGO; TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for cetirizine hydrochloride oral solution USP, 1 mg/mL, bubble gum flavored, the store brand equivalent to Children's Zyrtec® Allergy Syrup, 1 mg/mL, bubble gum flavored. |
| 2010-07-26 | Perrigo Company | Regulatory Perrigo Announces FDA Approval for Over-the-Counter Cetirizine Cherry Syrup perrigo.com ↗
Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market over-the-counter (OTC) Cetirizine Cherry Syrup, 1mg/ml. |
| 2008-06-19 | Perrigo Company | Regulatory Perrigo Announces Approval for Rx Cetirizine Syrup perrigo.com ↗
Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market Cetirizine Hydrochloride Syrup (Rx only), 1mg/mL. |
| 2008-04-14 | Perrigo Company | Regulatory Perrigo Announces Approval for Over-the-Counter Children's Cetirizine Oral Solution perrigo.com ↗
Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market over-the-counter (OTC) Children's Cetirizine Hydrochloride Oral Solution (Allergy) and Children's Cetirizine Hydrochloride Oral Solution (Hives-Relief), 1mg/mL. |
| 2008-03-18 | Orexo AB | Results Orexo’s product NLA Nasal Spray shows excellent local tolerability in patients with rhinitis orexo.com ↗
A newly completed study with rhinitis patients also shows that NLA Nasal Spray causes no side effects such as smarting pain in the nose. |
| 2008-03-06 | Perrigo Company | Regulatory Perrigo Company to Market Over-the-Counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets perrigo.com ↗
has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for over-the-counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets, 5 mg/120 mg. |
| 2007-12-28 | Perrigo Company | Regulatory Perrigo Announces FDA Approval for Over-The-Counter Cetirizine Hydrochloride Tablets perrigo.com ↗
Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Cetirizine Hydrochloride Tablets, 5 and 10 mg. |
| 2004-09-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Cetirizine Hcl Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Cetirizine Hydrochloride Tablets, 5 mg and 10 mg. |
All press releases naming this drug 19 releases
Evidence & citations 40 cited values
Every value below carries the sentence it was read from. 108 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | cetirizine | “This was a multi-center, parallel group, randomized, double-blind, active controlled, Phase III clinical trial of cetirizine injection 10 mg/mL versus diphenhydramine injection...” NCT02935699 ↗94“Subjects are requested to administer oral antihistamine (cetirizine) or nasal glucocorticosteroid (ciclesonide) as rescue medication for allergic rhinitis in accordance with...” NCT02665754 ↗ “A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of Cetirizine 0.24% Ophthalmic Solution (Formula AFH-002) Compared...” NCT01551056 ↗ “A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Cetirizine 0.1%/Fluticasone 0.005% Ophthalmic Solution Compared to Its Components and Vehicle in a...” NCT01134328 ↗ “Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10...” NCT00866788 ↗ “Cetirizine 10 mg and famotidine 20 mg will be dispensed to each patient, to be taken twice a day at 6-9AM one hour before eating breakfast and again at evening 12 hours after...” NCT04612803 ↗ “This 6-month randomized controlled pilot study will determine whether there is some evidence that cetirizine is better tolerated than diphenhydramine without an increase in IRRs.” NCT04175834 ↗ “The antihistamine used should in general be an H1\>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg.” NCT02604212 ↗ “a combination of cetirizine (CET) and pseudoephedrine (PSE), shows an equivalent treatment effect within and outside of the grass pollen season when tested in an ECC.” PMID 21457883 ↗ Feb 2011 “would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg.” NCT02604199 ↗ “would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg.” NCT02738008 ↗ |
| Known as | AC-170 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01495338 ↗ |
| Known as | AFH-002 | “Cetirizine 0.24% Ophthalmic Solution (Formula AFH-002)” NCT01551056 ↗ |
| Known as | Allacan | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Allertek | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Becoallergy | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Cetec | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Cetiderm | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Cetirizina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Cetirizine dihydrochloride | “Cetirizine dihydrochloride (10 mg/ml) liposomal formulation” NCT00533637 ↗1“cetirizine dihydrochloride (rescue medication)” NCT00610584 ↗ |
| Known as | Cetirizine HCl | “Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg Tablets (Sandoz, USA)” NCT00881634 ↗3“Cetirizine HCl/Pseudoephedrine HCl 5 mg/120 mg (Sandoz, USA)” NCT00881127 ↗ “Cetirizine HCl Tablets 10 mg” NCT00650065 ↗ |
| Known as | cetirizine hydrochloride | “The subjects received a single dose of 1-2 ml of the injection of cetirizine hydrochloride (administered by intravenous push) and a 1 ml dose of the injection simulant of...” NCT06819774 ↗ |
| Known as | Cetirizine hydrochloride allergy | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Cetirizine hydrochloride component of zyrtec-d | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Cetirizine hydrochloride hives | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Cetirizine hydrochloride hives relief | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Cetirocol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Cetrine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Children's cetirizine hydrochloride allergy | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Children's cetirizine hydrochloride hives relief | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Children's zyrtec allergy | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Children's zyrtec hives relief | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | CTZ DS | “Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup (CTZ DS) (2.5 mg or 5 mg Twice a Day)” NCT00490204 ↗ |
| Known as | JDP-205 | “This is a multicenter, parallel group, randomized, double-blind pilot Phase III clinical study of JDP-205 (cetirizine) injection, versus diphenhydramine injection, 50 mg/mL...” NCT02023164 ↗ |
| Known as | NSC-759102 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | P 071 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Piriteze | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Pollenshield | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Quzyttir | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Zerviate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Ziralton | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Zirtek | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Zynor | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Zyrtec | “Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single dose, single day” NCT00779116 ↗5“Zyrtec® (cetirizine) Chewable Tablets, 1 tablet (5 mg), oral administration, single day” NCT00780403 ↗ “the marketed cetirizine oral product Zyrtec® 10 mg tablets” NCT02024152 ↗ “zyrtec 10mg, oral, one time” NCT01825655 ↗ “cetirizine (zyrtec)” NCT00826943 ↗ |
| Known as | Zyrtec allergy | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Known as | Zyrtec hives relief | ChEMBL registry synonym — accepted as the source's own label CHEMBL1000 ↗ |
| Action | Inhibit | “Histamine H1 receptor antagonist” CHEMBL1000 ↗1“Histamine receptor antagonist” NCT03167216 ↗ |
| Modality | Other / unclassified | “long acting antihistamine like cetirizine” NCT01825655 ↗ |
| Route | Oral | “Oral Zyrtec® 10 mg tablet” NCT00240032 ↗ |
| Target | HRH1 | “Histamine H1 receptor antagonist” CHEMBL1000 ↗ |