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  • TABLET;ORAL - 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218461

FDA
14 Mar 2024

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-24-2024-24602.pdf

FDA
24 Jan 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217605

FDA
16 Jan 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217669

FDA
20 Dec 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217330

FDA
17 Aug 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-july-26-2023-55742.pdf

FDA
26 Jul 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217137

FDA
07 Jul 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217655

FDA
16 Jun 2023

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/marksans-pharma-gets-final-usfda-nod-for-generic-version-of-famotidine-tablets/articleshow/98538255.cms

ECONOMIC TIMES
10 Mar 2023

https://www.indianpharmapost.com/news/zydus-receives-final-approval-from-usfda-for-famotidine-injection-13334

INDIANPHARMAPOST
24 Nov 2022

https://www.fiercepharma.com/pharma/opening-round-zantac-litigation-gsk-scores-decisive-win

Kevin Dunleavy FIERCEPHARMA
17 Aug 2022

https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-sanofi-haleon-shares-stabilise-after-zantac-litigation-slump-2022-08-12/

Natalie Grover REUTERS
12 Aug 2022

https://www.businesswire.com/news/home/20220811005562/en/Amneal-launches-4-new-Generic-products-including-Vasopressin-single-dose

BUSINESSWIRE
11 Aug 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216427

FDA
04 Aug 2022

https://www.expresspharma.in/zydus-lifesciences-receives-final-approval-from-us-fda-for-famotidine-tablets/

EXPRESS PHARMA
06 Jun 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216441

FDA
03 Jun 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216441

FDA
03 Jun 2022

https://www.pharmacytimes.com/view/camber-pharma-launches-generic-pepcid-

PHARMACYTIMES
02 Jun 2022

https://www.businesswire.com/news/home/20220519005835/en

BUSINESSWIRE
19 May 2022

https://www.businesswire.com/news/home/20220210005964/en

BUSINESSWIRE
10 Feb 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215822

FDA
28 Jan 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215630

FDA
07 Jan 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215766

FDA
15 Nov 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215767

FDA
10 Nov 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216030

FDA
05 Nov 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215689

FDA
19 Oct 2021

https://www.indiainfoline.com/article/news-sector-pharma-healthcare/lupin-launches-authorized-generic-version-of-duexis-in-the-us-121091600302_1.html#:~:text=Ibuprofen%20and%20Famotidine%20Tablets%20(RLD,(IQVIA%20MAT%20July%202021).&text=Lupin%20has%20announced%20the%20launch,mg%2C%20of%20Horizon%20Medicines%20LLC.

INDIAINFOLINE
15 Sep 2021

http://www.pharmabiz.com/NewsDetails.aspx?aid=142535&sid=2

PHARMABIZ
15 Sep 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211890

FDA
03 Aug 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-10-2021-1615353629.pdf

FDA
10 Mar 2021

https://www.moneycontrol.com/news/business/dr-reddys-launches-generic-product-in-the-us-to-treat-gastroesophageal-reflux-disease-5987901.html

MONEYCONTROL
19 Oct 2020

https://www.raps.org/news-and-articles/news-articles/2020/3/covid-19-therapeutics-tracker

Jeff Craven RAPS
02 Oct 2020

https://www.medpagetoday.com/infectiousdisease/covid19/88119?xid=nl_mpt_DHE_2020-08-18&eun=g655567d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202020-08-18&utm_term=NL_Daily_DHE_dual-gmail-definition

Molly Walker MEDPAGETODAY
18 Aug 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-july-29-2020-1596012065.pdf

FDA
29 Jul 2020

https://www.sciencenews.org/article/coronavirus-covid-19-heartburn-medicine-pepcid-does-not-work-antiviral

Tina Hesman Saey SCIENCENEWS
27 Jul 2020

https://english.alarabiya.net/en/coronavirus/2020/05/24/Clinical-trials-of-coronavirus-drug-favipiravir-enter-final-stage.html

Matthew Amlôt ENGLISH
26 May 2020

https://www.business-standard.com/article/companies/famotidine-shortage-in-us-may-benefit-indian-pharmaceutical-companies-120050701419_1.html

Sohini Das BUSINESS-STANDARD
07 May 2020

https://www.cnbc.com/2020/04/28/heartburn-drug-trial-shows-reasonable-confidence-famotidine-could-help-treat-coronavirus-hospital-ceo-says-.html

Noah Higgins-Dunn CNBC
30 Apr 2020

https://edition.cnn.com/2020/04/27/health/famotidine-coronavirus-northwell-trial/index.html

Elizabeth Cohen CNN
27 Apr 2020

https://www.fiercepharma.com/manufacturing/need-a-safe-antacid-for-heartburn-fda-declares-pepcid-nexium-and-others-free-ndma

Eric Palmer FIERCE PHARMA
24 Oct 2019

https://www.pharmacompass.com/pdf/news/duexis-ibuprofen-and-famotidine-horizon-pharma-inc-and-horizon-pharma-usa-inc-v-alkem-laboratories-ltd-1531314741.pdf

PATENT LITIGATION
11 Jul 2018

https://www.fiercepharma.com/pharma/specialty-pharmacy-scrutiny-hits-again-state-s-focus-horizon-meds

Tracy Staton FIERCE PHARMA
09 Dec 2017

http://www.firstpost.com/business/dr-reddys-lab-recalls-famotidine-tablets-from-us-market-as-drug-fails-impurities-specifications-4159935.html

FIRST POST
21 Oct 2017

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-18-2017-1508294527.pdf

FDA
18 Oct 2017

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-13-2017-1505277974.pdf

FDA
13 Sep 2017

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-9-2017-1502256126.pdf

FDA
09 Aug 2017

http://www.cbsnews.com/news/heartburn-acid-reflux-drugs-ppi-associated-with-increased-risk-kidney-damage/

CBS NEWS
23 Feb 2017

http://www.fiercepharma.com/pharma/look-out-valeant-horizon-et-al-payers-patients-target-pricey-meds-combo-cheap-generics

Tracy Staton FIERCE PHARMA
01 Nov 2016

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/aurobindo-pharma-gets-us-food-and-drug-administration-nod-for-two-drugs/articleshow/52006823.cms

ECONOMIC TIMES
26 Apr 2016

http://www.pharma-excipients.ch/2016/03/03/enhancing-the-stability-of-a-famotidine-tablet-formulation-through-use-ofstarch-1500/

PHARMAEXCIPIENTS
03 Mar 2016
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