Drugs / Famotidine
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | PEPCID AC | — | 1998-11-09 – 2007-12-17 | fda.gov ↗ |
| Label expansions (3) | US (FDA) | PEPCID | — | 1988-10-17 – 2002-06-06 | fda.gov ↗ |
| Approved | US (FDA) | PEPCID | — | 1986-10-15 | fda.gov ↗ |
Trials 62 · started per year
today
US approved 1986
1
1
1
2
7
2
2
1
4
1
2
1
1
4
9
8
1
4
4
4
2
1986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 126 trials | ||||||
| Phase 1 | NCT06507904 | Sep 2026 → Feb 2027 expected | — | Pfizer | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07018635 | Jul → Sep 2025 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06170723 | Mar → May 2024 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06213818 | Mar 2024 → Aug 2025 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06054464 | Sep → Nov 2023 | — | PMV Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT05866627 | Jul → Sep 2023 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04935112 | Jul → Aug 2021 | — | Mirati Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04941755 | Jun → Sep 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04903093 | Jun → Oct 2021 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04545008 | Oct 2020 → Jun 2021 | COVID-19 | Prisma Health-Upstate | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04540965 | Sep → Dec 2020 | — | Calithera Biosciences, Inc | Completed | No outcome recorded |
| Phase 1 | NCT04453189 | Jul → Sep 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04470778 | Jul 2020 → Mar 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT05599828 | Jul → Sep 2020 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT04390334 | May → Jun 2020 | — | Idorsia Pharmaceuticals Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04179071 | Dec 2019 → Mar 2020 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03451110 | Feb → Mar 2018 | — | Eisai Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03302845 | Sep → Oct 2017 | — | Lexicon Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02097329 | Apr → Jun 2014 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT01841489 | May → Aug 2013 | chronic lymphocytic leukemia/small lymphocytic lymphoma | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT01734759 | Nov 2012 → Jan 2013 | — | Mayo Clinic | Completed | No outcome recorded |
| Phase 1 | NCT01000818 | Jun 2008 → Mar 2009 | HIV infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00451880 | Feb 2007 → Oct 2011 | colorectal cancer, melanoma, non-small cell lung carcinoma, thyroid gland papillary carcinoma | Exelixis | Completed | No outcome recorded |
| Phase 1 | NCT00422097 | Jan 2007 → Aug 2009 | cancer | R-Pharm | Completed | No outcome recorded |
| Phase 1 | NCT00365339 | Apr → Jun 2006 | HIV infectious disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT01511731 | Oct 1998 | — | Dr. Reddy's Laboratories Limited | Completed | No outcome recorded |
| Phase 27 trials · 2 missed | ||||||
| Phase 2 | NCT07857941 | Jan 2025 → Dec 2026 expected | — | Buddhist Tzu Chi General Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05085574 | Feb 2023 | COVID-19 | Leidos Life Sciences | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05077332 | Dec 2021 → Nov 2025 | COVID-19 | Leidos Life Sciences | Completed | No outcome recorded |
| Phase 2 | NCT05077969 | Dec 2021 → Jun 2022 | COVID-19 | Leidos Life Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04488081 | Jul 2020 → Jul 2028 expected | COVID-19 | QuantumLeap Healthcare Collaborative | Active not recruiting | Missed primary |
| Phase 2 | NCT04248712 | Jul 2020 → Dec 2021 | eosinophilic esophagitis | Mayo Clinic | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03554291 | May 2019 → Jul 2023 | heart failure, pulmonary arterial hypertension | University of Washington | Completed | Missed primary |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05084521 | Jan → Dec 2022 | sickle cell disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2/3 | NCT01946295 | Mar 2014 → Aug 2016 | schizophrenia | Jesper Ekelund | Unknown | No outcome recorded |
| Phase 2/3 | NCT00141960 | Sep 2005 → ? | gastroesophageal reflux disease | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT06801626 | Mar 2025 → Dec 2027 expected | — | The University of Texas Medical Branch, Galveston | Recruiting | No outcome recorded |
| Phase 3 | NCT05946551 | Mar → Jun 2024 | COVID-19 | Emory University | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04504240 | Aug 2020 → Apr 2021 | COVID-19 | Chattogram General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT00984815 | Sep 2009 → Jul 2011 | complex regional pain syndrome, osteoarthritis, rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00613106 | Sep 2007 → Oct 2008 | complex regional pain syndrome, osteoarthritis, rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00450658 | Mar 2007 → Sep 2008 | peptic ulcer disease | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00450216 | Mar 2007 → Aug 2008 | ulcer disease | Amgen | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT05455359 | Feb 2025 → May 2027 expected | aspiration pneumonia, dyskinesia of esophagus, functional gastric disease, gastroesophageal reflux disease | Boston Children's Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04836806 | Aug 2021 → Jul 2022 | COVID-19 | Emory University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04565392 | May → Nov 2021 | COVID-19 | drpykessupplements.com | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01563185 | Apr 2012 → Mar 2015 | juvenile idiopathic arthritis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT02703896 | Jan 2012 | lung disorder | King Saud University | Completed | No outcome recorded |
| Phase 4 | NCT01232127 | Feb → Jun 2011 | HIV infectious disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT00950339 | Aug 2009 → Jun 2011 | coronary artery disorder | Tel-Aviv Sourasky Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00565175 | Jan 2008 → Dec 2011 | schizophrenia | Jesper Ekelund | Completed | No outcome recorded |
| Phase 4 | NCT00384904 | Dec 2006 → Dec 2007 | HIV infectious disease | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT01928888 | May 2003 → Feb 2004 | dyspepsia | Bayer | Completed | No outcome recorded |
| Phase not applicable9 trials | ||||||
| — | NCT07539961 | Sep 2026 → Dec 2027 expected | calcific tendinitis | University Hospital Dubrava | Not yet recruiting | No outcome recorded |
| — | NCT06629337 | Apr → Aug 2024 | hypertensive disorder | California Baptist University | Completed | No outcome recorded |
| — | NCT06313307 | Apr → Nov 2023 | hyperpigmentation of the skin | Second Affiliated Hospital of Xi'an Jiaotong University | Completed | No outcome recorded |
| — | NCT05131555 | Aug → Dec 2021 | — | University Ghent | Completed | No outcome recorded |
| — | NCT04123899 | Oct → Nov 2019 | peptic ulcer disease | Dong-A ST Co., Ltd. | Unknown | No outcome recorded |
| — | NCT04450134 | Oct → Dec 2019 | — | University Ghent | Completed | No outcome recorded |
| — | NCT02551744 | Jul 2012 → Jul 2018 | peptic ulcer disease | Kaohsiung Veterans General Hospital. | Completed | No outcome recorded |
| — | NCT01079052 | Nov 2007 | — | Ranbaxy Laboratories Limited | Completed | No outcome recorded |
| — | NCT01079065 | Nov 2007 | — | Ranbaxy Laboratories Limited | Completed | No outcome recorded |
| Comparator or background therapy66 trials | ||||||
| Phase 1 | NCT07629999 Background | Jun 2026 → Jun 2027 expected | — | Bristol-Myers Squibb | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07171619 Comparator | Aug → Nov 2025 | — | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT06789172 Background | Jan 2025 → Jul 2028 expected | colorectal cancer, dedifferentiated liposarcoma, gastric adenocarcinoma, gastroesophageal adenocarcinoma +6 | Epkin | Recruiting | No outcome recorded |
| Phase 1 | NCT06332638 Comparator | Mar → Jul 2024 | — | HK inno.N Corporation | Unknown | No outcome recorded |
| Phase 1 | NCT06144697 Background | Jan → Oct 2024 | — | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT05035407 Background | Mar 2022 → Jul 2025 | — | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 1 | NCT04949269 Background | Jul 2021 → Jan 2022 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04840615 Background | Jun → Dec 2021 | mesothelioma | National Cancer Institute (NCI) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04550195 Background | Sep 2020 → Mar 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04536961 Background | Sep → Dec 2020 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04209699 Background | Dec 2019 → Feb 2020 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04175925 Background | Nov 2019 → Jul 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03805932 Background | Oct 2019 → Jul 2023 overdue | hairy cell leukemia | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04065932 Background | Aug → Dec 2019 | lupus erythematosus | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03330028 Background | Oct 2017 → Apr 2023 | upper digestive tract disorder | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT03142165 Background | May → Nov 2017 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02763969 Background | May → Dec 2016 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02684799 Comparator | Jan → Apr 2016 | — | Tobira Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02534636 Background | Oct 2015 → Nov 2016 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT06481306 Background | Jul 2024 → Apr 2028 expected | sickle cell disease | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06265077 Comparator | Feb → Oct 2024 | breast cancer | Noha Mansour | Completed | No outcome recorded |
| Phase 1/2 | NCT06207305 Background | Jan 2024 → Jan 2028 expected | appendix adenocarcinoma | M.D. Anderson Cancer Center | Recruiting | 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 1/2 | NCT04614974 Comparator | Nov 2020 → May 2024 | gastroesophageal reflux disease, laryngeal disorder | Reema Padia | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06819670 Comparator | May 2025 → Feb 2028 expected | infantile spasms | University of California, Los Angeles | Recruiting | No outcome recorded |
| Phase 2 | NCT06706258 Comparator | Jan 2025 → Dec 2026 expected | acute kidney injury | The University of Texas Health Science Center, Houston | Recruiting | No outcome recorded |
| Phase 2 | NCT06154226 Comparator | Jan → Sep 2024 | acute kidney injury | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2 | NCT05977998 Background | Sep 2023 → Oct 2028 expected | gastric adenocarcinoma, metastatic carcinoma | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04918147 Background | Oct 2021 → Jan 2024 | immunoglobulin G4-related sclerosing disease | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT04724720 Comparator | Jan → May 2021 | COVID-19 | Northwell Health | Completed | No outcome recorded |
| Phase 2 | NCT04621149 Comparator | Nov 2020 → Mar 2022 | COVID-19 | Profact, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04308837 Background | Dec 2018 → Aug 2025 | gastric cancer | Icahn School of Medicine at Mount Sinai | Unknown | No outcome recorded |
| Phase 2 | NCT03107182 Background | Jun 2017 → Sep 2024 | head and neck squamous cell carcinoma, human papillomavirus-related squamous cell carcinoma | University of Chicago | Completed | No outcome recorded |
| Phase 2 | NCT02142712 Background | Dec 2014 | brain edema, stroke disorder | University of Florida | Completed | No outcome recorded |
| Phase 2 | NCT01937078 Comparator | Apr 2011 → Mar 2014 | movement disorder | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2/3 | NCT04862585 Comparator | Oct 2021 → Jun 2024 | breast carcinoma in situ, female breast carcinoma | Ohio State University Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2/3 | NCT05043350 Background | Sep 2021 → Jul 2022 | COVID-19 | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT05965492 Background | Jun 2024 → Jun 2025 | spinal cord disorder | University of Miami | Withdrawn | No outcome recorded |
| Phase 3 | NCT05024721 Comparator | Aug 2021 → Mar 2022 | gastritis | Hanmi Pharmaceutical Company Limited | Completed | Met primary |
| Phase 3 | NCT04340297 Background | Jun 2020 → Dec 2021 | gastroesophageal reflux disease | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Unknown | No outcome recorded |
| Phase 3 | NCT04370262 Comparator | Apr → Sep 2020 | COVID-19 | Northwell Health | 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 | NCT03647072 Comparator | Aug 2018 → Oct 2027 expected | lymphoma | Tanta University | Recruiting | No outcome recorded |
| Phase 3 | NCT01499368 Comparator | Nov 2011 → Nov 2012 | esophagitis | Boryung Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT01408186 Comparator | Jan 2011 → Nov 2015 | peptic ulcer disease | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 3 | NCT00229424 Comparator | Apr 2005 → Oct 2006 | gastroesophageal reflux disease | Taiho Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT07101445 Background | Sep 2025 → Dec 2026 expected | plasma cell myeloma | Emory University | Recruiting | No outcome recorded |
| Phase 4 | NCT06743243 Comparator | Jul 2025 → Oct 2026 expected | — | Seok Kyeong Oh | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06241183 Comparator | Nov 2023 → Dec 2027 expected | dyspepsia, gastroesophageal reflux disease | Stony Brook University | Recruiting | No outcome recorded |
| Phase 4 | NCT04990804 Background | Aug 2021 → Feb 2022 | spinal cord disorder, substance-related disorder | Vanderbilt University Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT04766996 Background | May → Dec 2021 | substance-related disorder | Emory University | Terminated | No outcome recorded |
| Phase 4 | NCT03667703 Comparator | Mar 2019 → Jun 2022 | congenital heart disease, infectious disease, peptic ulcer disease | Boston Children's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01180179 Comparator | Jun 2010 → May 2019 | peptic ulcer disease | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 4 | NCT01062516 Comparator | Jan → Sep 2010 | acute coronary syndrome, acute myocardial infarction | Ruttonjee Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00978159 Comparator | Sep 2009 → Dec 2013 | dyspepsia | Ruttonjee Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00683111 Comparator | Jul 2008 → Dec 2011 | acute coronary syndrome, acute myocardial infarction | Ruttonjee Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00839488 Comparator | Apr 2008 → Mar 2009 | gastric ulcer | Far Eastern Memorial Hospital | Terminated | No outcome recorded |
| Phase 4 | NCT00633035 Comparator | Sep 2007 → Mar 2010 | ulcer disease | Far Eastern Memorial Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00557349 Comparator | Nov 2006 → Nov 2007 | ulcer disease | University of Missouri-Columbia | Completed | No outcome recorded |
| Phase 4 | NCT00843063 Comparator | Aug 2004 → Dec 2008 | peptic ulcer disease | Ruttonjee Hospital | Completed | No outcome recorded |
| — | NCT06211088 Comparator | Aug → Dec 2024 | — | Aswan University Hospital | Completed | No outcome recorded |
| — | NCT04463420 Background | Aug → Nov 2020 | COVID-19 | Baqiyatallah Medical Sciences University | Unknown | No outcome recorded |
| — | NCT02473042 Background | Mar 2016 → Nov 2024 | breast cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| — | NCT02700087 Comparator | Feb 2016 → Feb 2017 | gastroesophageal reflux disease, laryngeal disorder | Stanford University | Withdrawn | No outcome recorded |
| — | NCT02410460 Background | Sep 2013 → Jun 2014 | — | Mercy Facial Plastic Surgery Center | Completed | No outcome recorded |
| — | NCT02418312 Comparator | Jan 2012 → Oct 2017 | peptic ulcer disease | Kaohsiung Veterans General Hospital. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2026-05-13 | Lupin Limited | Regulatory Lupin Receives U.S. FDA Approval for Famotidine Injection, USP lupin.com ↗
Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration for its Abbreviated New Drug Applications for Famotidine Injection USP, 20 mg/2 mL (10 mg/mL), Single-Dose Vials. |
| 2022-11-23 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Famotidine Injection zyduslife.com ↗
Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Famotidine Injection USP, 40 mg/4 mL (10 mg/mL) and 200 mg/20 mL (10 mg/mL) multiple-dose vials (USRLD: Pepcid® injection). |
| 2022-08-11 | Impax Laboratories, LLC | Regulatory Amneal launches 4 new Generic products, including Vasopressin single-dose amneal.com ↗
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (“FDA”) for four generics products, including vasopressin injection 1mL (single-dose). |
| 2022-06-06 | Zydus Lifesciences Limited | Regulatory Press Release Zydus Lifesciences receives final approval from USFDA for Famotidine Tablets zyduslife.com ↗ |
| 2009-07-13 | Astellas Pharma Inc | Results DATA ON GASTER® SHOW PREVENTION OF PEPTIC ULCERS IN USERS OF LOW-DOSE ASPIRINE - "FAMOUS trial" reported in The Lancet - astellas.com ↗
The results of FAMOUS study demonstrated that famotidine can inhibit gastrointestinal disorders in patients with cardiovascular diseases, cerebrovascular diseases or diabetes who are taking low-dose aspirin. |
| 2009-06-02 | Astellas Pharma Inc | Results NEWLY PRESENTED DATA ON GASTER® SHOW PREVENTION OF PEPTIC ULCERS IN USERS OF LOW-DOSE ASPIRINE astellas.com ↗
After 12 weeks of treatment, incidence of all lesions diagnosed with endoscope in patients taking Gaster showed significant difference (p<0.00001) in this trial (5.9% in patients taking Gaster 20-mg twice daily and 33.0% in patients taking placebo). |
| 2008-02-12 | Perrigo Company | Regulatory Perrigo Company Announces Final FDA Approval for OTC Famotidine Complete Chewable 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 (FDA) for its Abbreviated New Drug Application (ANDA) for over-the-counter Famotidine 10 mg, Calcium Carbonate 800 mg, and Magnesium Hydroxide 165 mg, Chewable Tablets. |
| 2006-09-25 | Perrigo Company | Regulatory Perrigo Announces Approval for Famotidine Tablets perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to manufacture and market over-the- counter (OTC) Famotidine tablets, USP, 20 mg. |
| 2005-09-12 | Perrigo Company | Regulatory Perrigo Company Announces Tentative Approval for Famotidine Tablets perrigo.com ↗
The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Famotidine Tablets USP, 20 mg (OTC). |
| 2001-05-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Final Approval of Famotidine Tablets,10mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd.(Nasdaq:TEVA)announced today that the U.S. Food and Drug Administration (FDA)has awarded final approval for Famotidine TabletsUSP,10 mg. |
| 2001-04-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Final Approval of Famotidine 20 & 40mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has awarded final approval for Famotidine 20mg and 40mg tablets, upon expiration of the patent on April 15, 2001. |
All press releases naming this drug 15 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 129 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Famotidine | “HZT-501, a fixed-dose combination of ibuprofen, a pain and inflammation relieving non-steroidal anti-inflammatory drug (NSAID), and famotidine, a histamine type 2 receptor...” NCT00984815 ↗125“The subject should maintain a minimum of 10 hours of empty stomach before administration, and swallow an oral dose of 1 tablets (Famotidine 20 mg) after moistening mouth with...” NCT04123899 ↗ “Topical H2RA (2% famotidine solution solved in double-distilled water (containing poloxamer 407, glycerol, lauryl alcohol polyether-4, polyethylene glycol-8, and propylene...” NCT06313307 ↗ “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 ↗ “The patients will be randomly assigned to receive either (1) famotidine (40 mg qd) plus thienopyridine used previously or (2) placebo plus thienopyridine treatment alone for 6 months.” NCT02418312 ↗ “Subjects ingested fexofenadine (540 mg, tablet) at least 50 minutes before and famotidine (40 mg, tablet) 1 hour 50 minutes before the onset of each protocol” NCT06629337 ↗ “Famotidine is a marketed medicine which decreases the amount of acid made in the stomach and is used to prevent and treat heartburn.” NCT06507904 ↗ “Therefore, this study compared the efficacy and safety of HIP2101 and 20-mg famotidine (RLD2101) in patients with gastric erosions.” PMID 39949051 ↗ Feb 2025 “in the 3-4 weeks, acid inhibitor was changed from PPI to famotidine tablets, 20mg each time, before going to bed” NCT04340297 ↗ “Famotidine 20mg/10ml+saline 10ml IV + Tegoprazan OD tab. 50 mg placebo PO, one hour before general anesthesia.” NCT06743243 ↗ “Famotidine (20mg BID) or Omeprazole (20mg daily) will be prescribed along with NSAIDS for GI prophylaxis” NCT04990804 ↗ |
| Known as | FAM | “group three received famotidine (FAM) 40 mg p.o. once daily one week before cycle” PMID 33394214 ↗ Jan 20211“Famotidine (FAM)” NCT01232127 ↗ |
| Known as | Pepcid | “Famotidine (Pepcid), a histamine H2 antagonist widely available over-the-counter” NCT04370262 ↗6“Famotidine (Pepcid) will be given at 6 different timepoints:” NCT06706258 ↗ “20mg of oral famotidine (pill) daily Other names: Pepcid” NCT03554291 ↗ “oral famotidine (Pepcid)” NCT06801626 ↗ “Pepcid 40 mg Tablets” NCT01511731 ↗ |
| Known as | Pepcid AC | “This research is to determine which medication, Zegerid (Omeprazole/Sodium Bicarbonate) or Pepcid AC (Famotidine), works best at reducing the chance that a patient will get an...” NCT00557349 ↗1“Pepcid® AC Acid reducer famotidine tablets 20 mg (containing famotidine 20 mg)” NCT01079065 ↗ |
| Known as | Pepcid AC Acid reducer | “Pepcid® AC Acid reducer famotidine tablets 20 mg (containing famotidine 20 mg) distributed by Johnson \& Johnson. Merck Consumer Pharmaceutical Co. Fort Washington, PA 19034...” NCT01079052 ↗ |
| Known as | RLD2101 | “Therefore, this study compared the efficacy and safety of HIP2101 and 20-mg famotidine (RLD2101) in patients with gastric erosions.” PMID 39949051 ↗ Feb 2025 |
| Action | Inhibit | “blockade of the histamine H2 receptors in the brain” NCT00565175 ↗ |
| Modality | Other / unclassified | “a histamine 2 receptor antagonist (famotidine)” NCT01180179 ↗ |
| Route | Oral | “Oral administration of famotidine by 40mg/day along with lafutidine placebo” NCT00229424 ↗ |
| Target | SELP | “famotidine may prevent vaso-occlusion by decreasing P-selectin expression by endothelial cells.” NCT05084521 ↗ |