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  • TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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=213019

FDA
19 Mar 2024

https://www.indianpharmapost.com/news/shilpa-medicare-gets-europe-approval-for-varenicline-tablets-05mg-and-1mg-15315

INDIAN PHARMA POST
26 Feb 2024

https://www.indianpharmapost.com/news/lupin-launches-varenicline-tablets-in-us-15132

INDIAN PHARMA POST
11 Jan 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214557

FDA
23 Aug 2023

https://www.reuters.com/legal/litigation/endo-sues-zydus-block-generic-version-pfizers-chantix-2023-08-09/

REUTERS
11 Aug 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214255

FDA
01 Aug 2023

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-varenicline-tartrate-nasal-spray-73853.pdf

FDA
15 Jun 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216723

FDA
12 Jun 2023

https://www.globenewswire.com/news-release/2022/08/17/2499937/0/en/Oyster-Point-Pharma-Announces-TYRVAYA-To-Be-Covered-By-the-Largest-Medicare-Pharmacy-Benefit-Manager.html

GLOBENEWSWIRE
17 Aug 2022

https://www.fiercebiotech.com/biotech/oyster-point-ploughs-ahead-50-layoffs-part-focus-approved-eye-drug

James Waldron FIERCE BIOTECH
12 Aug 2022

https://lawstreetmedia.com/news/health/chantix-lawsuit-against-pfizer-dismissed/

Erin Page LAWSTREET
18 Feb 2022

https://www.reuters.com/business/healthcare-pharmaceuticals/lawsuit-over-pfizers-disclosures-before-chantix-recall-is-dismissed-2022-02-16/

Jonathan Stempel REUTERS
16 Feb 2022

https://www.psychiatryadvisor.com/home/topics/addiction/tobacco-use-disorder/most-monotherapies-and-combinatorial-therapies-were-more-effective-than-placebo/

Jessica Nye PSYCHIATRYADVISOR
18 Jan 2022

https://www.globenewswire.com/news-release/2021/11/24/2340467/0/en/Oyster-Point-Pharma-Announces-Expansion-of-Executive-Leadership-Team-to-Support-Commercialization-of-Tyrvaya-varenicline-solution-Nasal-Spray-for-the-Signs-and-Symptoms-of-Dry-Eye-.html

GLOBENEWSWIRE
24 Nov 2021

https://www.globenewswire.com/news-release/2021/11/03/2326869/0/en/Oyster-Point-Pharma-s-TYRVAYA-varenicline-solution-Nasal-Spray-is-Now-Available-at-U-S-Regional-Wholesalers-for-Distribution-to-Pharmacies-for-the-Treatment-of-the-Signs-and-Sympto.html

GLOBENEWSWIRE
03 Nov 2021

https://endpts.com/fda-oks-an-inhaled-version-of-smoking-cessation-drug-chantix-for-a-common-eye-disease/

P. Schloesser ENDPTS
19 Oct 2021

https://pharmaceutical-journal.com/article/news/pfizer-recalls-all-stock-of-smoking-cessation-medicine-over-nitrosamine-contamination

PHARMACEUTICAL JOURNALS
16 Oct 2021

https://www.gov.uk/drug-device-alerts/class-2-medicines-recall-pfizer-ltd-champix-all-strengths-film-coated-tablets-el-21-a-slash-25

GOVUK
14 Oct 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-29-2021-1632907538.pdf

FDA
29 Sep 2021

https://endpts.com/recall-report-pfizer-pulls-even-more-chantix-lots-as-nitrosamine-contamination-worries-grow/

Josh Sullivan ENDPTS
24 Sep 2021

https://www.prnewswire.com/news-releases/endo-launches-first-and-only-generic-version-of-chantix-varenicline-tablets-in-the-united-states-301382946.html

PRNEWSWIRE
22 Sep 2021

https://www.pharmacompass.com/pdf/news/pfizer-expands-voluntary-nationwide-recall-to-include-all-lots-of-chantix-varenicline-1631859239.pdf

FDA
16 Sep 2021

https://www.pharmacompass.com/pdf/news/pfizer-expands-voluntary-nationwide-recall-to-include-four-additional-lots-of-chantix-varenicline-tablets-1629188850.pdf

FDA
17 Aug 2021

https://www.fiercepharma.com/pharma/endo-s-smoking-cessation-generic-rushed-over-fda-s-finish-line-effort-to-fill-chantix

FIERCEPHARMA
13 Aug 2021

https://www.fiercepharma.com/pharma/endo-s-smoking-cessation-generic-rushed-over-fda-s-finish-line-effort-to-fill-chantix

Noah Higgins-Dunn  FIERCEPHARMA
12 Aug 2021

https://endpts.com/first-generic-competition-arrives-for-pfizers-megablockbuster-anti-smoking-drug/

Zachary Brennan ENDPTS
12 Aug 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-11-2021-1628658546.pdf

FDA
11 Aug 2021

https://www.medicalbag.com/home/news/for-smoking-cessation-cytisine-not-noninferior-to-varenicline-but-is-better-tolerated/

MEDICAL.BAG
03 Aug 2021

https://www.pharmacompass.com/pdf/news/pfizer-issues-a-voluntary-nationwide-recall-for-twelve-lots-of-chantix-varenicline-tablets-due-to-n-nitroso-varenicline-content-1626771322.pdf

FDA
20 Jul 2021

https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-voluntary-recall-varenicline-chantix-warehouse

FDA
02 Jul 2021

https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-patients-voluntary-recall-varenicline-chantix-warehouse#:~:text=the%20warehouse%20level-,FDA%20alerts%20health%20care%20professionals%20and%20patients%20to%20a%20voluntary,Chantix)%20to%20the%20warehouse%20level&text=%5B7%2F02%2F2021%5D,)%2C%20to%20the%20warehouse%20level.

FDA
02 Jul 2021

https://www.globenewswire.com/news-release/2021/06/29/2255209/0/en/Oyster-Point-Pharma-Provides-Key-Supply-Chain-Insight-For-OC-01-varenicline-Nasal-Spray.html

GLOBENEWSWIRE
29 Jun 2021

https://psnc.org.uk/our-news/supply-disruption-affecting-champix-varenicline-tablets-pfizer/

PSNC
22 Jun 2021

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75843r-eng.php

HEALTH CANADA
08 Jun 2021

https://www.globenewswire.com/news-release/2020/12/18/2147712/0/en/Oyster-Point-Pharma-Submits-New-Drug-Application-to-the-U-S-Food-and-Drug-Administration-for-OC-01-varenicline-Nasal-Spray-for-the-Treatment-of-Signs-and-Symptoms-of-Dry-Eye-Diseas.html

GLOBENEWSWIRE
18 Dec 2020

https://www.globenewswire.com/news-release/2020/12/18/2147712/0/en/Oyster-Point-Pharma-Submits-New-Drug-Application-to-the-U-S-Food-and-Drug-Administration-for-OC-01-varenicline-Nasal-Spray-for-the-Treatment-of-Signs-and-Symptoms-of-Dry-Eye-Diseas.html

GLOBENEWSWIRE
18 Dec 2020

https://www.biospace.com/article/releases/achieve-life-sciences-announces-results-from-evaluation-of-cytisinicline-cytisine-versus-chantix-varenicline-in-5-ht3-receptor-binding-assay-study/

BIOSPACE
18 Sep 2020

https://www.prnewswire.com/news-releases/achieve-announces-successful-results-from-the-investigator-initiated-rauora-head-to-head-non-inferiority-clinical-trial-comparing-cytisinicline-and-chantix-varenicline-as-a-treatment-to-quit-smoking-301084753.html

PRNEWSWIRE
29 Jun 2020

https://www.fiercepharma.com/pharma/pfizer-bms-gilead-abbvie-and-others-raise-prices-hundreds-medicines-to-ring-2020

E. Sagonowsky FIERCE PHARMA
03 Jan 2020

https://www.globenewswire.com/news-release/2019/11/22/1951624/0/en/Oyster-Point-Pharma-Announces-Positive-Top-Line-Results-From-the-Phase-1-ZEN-Study-of-Its-Lead-Nicotinic-Agonist-Nasal-Spray-in-Development-for-the-Treatment-of-Dry-Eye-Disease.html

GLOBE NEWSWIRE
26 Nov 2019

https://www.globenewswire.com/news-release/2019/11/22/1951624/0/en/Oyster-Point-Pharma-Announces-Positive-Top-Line-Results-From-the-Phase-1-ZEN-Study-of-Its-Lead-Nicotinic-Agonist-Nasal-Spray-in-Development-for-the-Treatment-of-Dry-Eye-Disease.html

GLOBE NEWSWIRE
22 Nov 2019

https://www.fiercepharma.com/marketing/hey-big-spenders-pharma-ranks-top-five-industries-for-tv-media-spending-says-report

Beth Snyder Bulik FIERCE PHARMA
16 May 2019

https://www.biospace.com/article/researchers-use-pfizer-s-anti-smoking-drug-chantix-to-control-neurons-/

Mark Terry BIOSPACE
15 Mar 2019

https://www.fiercebiotech.com/research/using-pfizer-s-chantix-to-control-neurons-for-drug-research

Angus Liu FIERCE BIOTECH
14 Mar 2019

https://www.fiercepharma.com/actor-ray-liotta-joins-pfizer-s-ad-campaign-for-chantix-featuring-real-people-who-quit-smoking

Beth Snyder Bulik FIERCE PHARMA
06 Jul 2018

https://www.fiercepharma.com/pfizer-hikes-price-smoking-cessation-drug-chantix-106-5-years-report

A. Weintraub FIERCE PHARMA
26 Jun 2018

http://www.koreabiomed.com/news/articleView.html?idxno=3372

KOREABIOMED
29 May 2018

http://www.biospace.com/News/how-pfizer-made-most-of-its-52-8-billion-last-year/452843/source=TopBreaking?intcid=homepage-seekernewssection-tabtopbreakingnews

Mark Terry BIOSPACE
19 Apr 2017

http://raps.org/Regulatory-Focus/News/2017/04/05/27281/FDA-Warns-Pfizer-Clinical-Investigator-Over-Chantix-Study/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails

Zachary Brennan RAPS
06 Apr 2017

http://www.pharmabiz.com/NewsDetails.aspx?aid=99304&sid=2

PHARMABIZ
20 Dec 2016
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