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  • SOLUTION;TOPICAL - 2%
  • SOLUTION;TOPICAL - 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CREAM;TOPICAL - 0.5%
  • CREAM;TOPICAL - 4%

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215612

FDA
02 Nov 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217676

FDA
18 Oct 2023

https://www.onclive.com/view/folfox-produces-varying-toxicity-profile-vs-chemoradiation-in-rectal-cancer

ONCLIVE
01 Jul 2023

https://www.expresspharma.in/alembic-pharma-gets-usfda-nod-for-fluorouracil-injection-usp-2-5-g-50-ml-pharmacy-bulk-vial/

EXPRESS PHARMA
06 Mar 2023

https://www.accessdata.fda.gov/scripts/ires/index.cfm?action=print.getPrintData&ts=11202310416

FDA
01 Feb 2023

https://www.businesswire.com/news/home/20220802006066/en

BUSINESSWIRE
03 Aug 2022

https://www.businesswire.com/news/home/20220803005334/en

BUSINESSWIRE
03 Aug 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214845

FDA
14 Oct 2021

http://www.pharmabiz.com/NewsDetails.aspx?aid=139687&sid=2

PHARMABIZ
01 Jul 2021

https://www.prnewswire.com/news-releases/phase-2-fight-trial-continues-to-show-improved-overall-survival-with-bemarituzumab-plus-chemotherapy-in-patients-with-fgfr2b-gastric-and-gastroesophageal-cancers-301305762.html

PRNEWSWIRE
07 Jun 2021

https://www.ema.europa.eu/en/news/ema-recommendations-dpd-testing-prior-treatment-fluorouracil-capecitabine-tegafur-flucytosine

EMA
01 May 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209271

FDA
13 Dec 2019

https://www.biospace.com/article/releases/merck-receives-positive-eu-chmp-opinion-for-two-new-regimens-of-keytruda-pembrolizumab-as-first-line-treatment-for-metastatic-or-unresectable-recurrent-head-and-neck-squamous-cell-carcinoma-/?s=95

BIOSPACE
19 Oct 2019

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-july-24-2019-1563965153.pdf

FDA
24 Jul 2019

https://www.pharmacompass.com/pdf/news/fresenius-kabi-issues-voluntary-nationwide-recall-of-two-lots-of-fluorouracil-injection-due-to-the-potential-for-glass-particulate-1562221289.pdf

FDA
01 Jul 2019

https://www.raps.org/news-and-articles/news-articles/2019/3/ema-begins-review-of-screening-patients-on-fluorou

Zachary Brennan RAPS
15 Mar 2019

https://www.pharmacompass.com/pdf/news/ema-approved-5-fluorouracil-list-of-nationally-authorised-medicinal-products-1556882145.pdf

EMA
19 Nov 2018

https://www.businesswire.com/news/home/20180918005158/en

BUSINESSWIRE
18 Sep 2018

https://endpts.com/merck-claims-a-needed-win-for-keytruda-with-interim-os-data-in-head-and-neck-cancer/

Amber Tong ENDPTS
24 Jul 2018

https://platform.mi.spglobal.com/web/client?auth=inherit#news/article?id=44401060&cdid=A-44401060-12348

Jonathan Chan PLATFORM
30 Apr 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210123

FDA
31 Oct 2017

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-22-2017-1490161550.pdf

FDA
22 Mar 2017

http://www.pharmabiz.com/NewsDetails.aspx?aid=99832&sid=2

PHARMABIZ
16 Jan 2017

http://www.pharmatimes.com/news/nice_rejects_shires_pancreatic_cancer_drug_1177060

Selina McKee PHARMATIMES
17 Nov 2016

http://www.prnewswire.com/news-releases/merrimack-and-baxalta-announce-initiation-of-phase-1-study-of-mm-151-in-combination-with-the-onivyde-irinotecan-liposome-injection-regimen-in-metastatic-colorectal-cancer-300271334.html

PR NEWSWIRE
19 May 2016

http://www.prnewswire.com/news-releases/pharmaengine-announces-korean-ministry-of-food-and-drug-safety-accepted-the-nda-filing-of-onivyder-for-the-treatment-of-metastatic-pancreatic-cancer-300266582.html

PR NEWSWIRE
10 May 2016

http://www.pharma-excipients.ch/2016/05/03/high-ester-pectin-based-formulation-for-site-specific-delivery-of-5-fluorouracil-in-to-descending-colon/

PHARMA-EXCIPIENTS
03 May 2016

https://www.pharmacompass.com/pdf/news/sagent-pharms-generic-fluorouracil-approved-in-us-for-treatment-of-cancer-1456398221.pdf

FDA
17 Feb 2016

http://www.prnewswire.com/news-releases/updated-data-shows-onivyde-irinotecan-liposome-injection-combination-regimen-increased-one-year-survival-by-63-in-patients-with-metastatic-pancreatic-cancer-300206741.html

PR NEWS WIRE
19 Jan 2016

http://www.prnewswire.com/news-releases/merrimack-to-present-updated-overall-survival-analysis-of-phase-3-napoli-1-study-of-onivyde-irinotecan-liposome-injection-at-the-american-society-of-clinical-oncology-asco-2016-gastrointestinal-cancers-symposium-300201996.html

PR NEWS WIRE
11 Jan 2016

https://www.pharmacompass.com/pdf/news/hill-dermacs-tolak-fluorouracil-approved-in-us-for-skin-cancer-1443008535.pdf

22 Sep 2015

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-1351-2015&w=09022015&lang=eng

FDA
05 Sep 2015

http://www.fda.gov/Safety/Recalls/ucm445584.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

FDA LAW BLOG
06 May 2015

http://www.fiercepharmamanufacturing.com/story/attix-pharmaceuticals-recalls-hundreds-apis-us/2015-04-30

Eric Palmer FIERCE PHARMA MFG
02 May 2015

https://investor.lilly.com/releasedetail.cfm?ReleaseID=908561

Press Release LILLY
25 Apr 2015

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm443595.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

Press Release FDA
21 Apr 2015
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