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  • CAPSULE;ORAL - 300MG;EQ 0.5MG BASE
  • SOLUTION;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)
  • POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL
  • SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)
  • INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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=215861

FDA
14 Aug 2023

https://www.globenewswire.com/news-release/2023/06/12/2686333/0/en/Helsinn-announces-publication-of-data-evaluating-impact-of-AKYNZEO-fosnetupitant-palonosetron-on-treatment-outcomes-and-healthcare-costs.html

GLOBENEWSWIRE
12 Jun 2023

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/glenmark-introduces-medication-to-prevent-chemotherapy-induced-nausea/articleshow/97243641.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

ECONOMIC TIMES
23 Jan 2023

https://www.globenewswire.com//news-release/2022/11/28/2562924/0/en/Farma-Mondo-Group-and-Helsinn-sign-exclusive-partnership-to-commercialize-AKYNZEO-in-the-Baltic-region.html

GLOBENEWSWIRE
28 Nov 2022

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-fosnetupitant-chloride-hydrochloride-and-palonosetron-hydrochloride-1655270132.pdf

FDA
13 Jun 2022

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-aprepitant-azilsartan-bupivacaine-cladribine-elrombopag-fosnetupitant-fostamatinib-ivacaftor-and-sodium-thiosulfate-1655270821.pdf

FDA
13 Jun 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206916

FDA
16 Nov 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=202951

FDA
29 Jun 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204615

FDA
23 Mar 2021

https://www.helsinn.com/news-and-events/helsinn-group-and-italfarmaco-announce-oral-presentation-of-nepa-netupitant-and-palonosetron-data-at-esmo-virtual-congress-2020/

PRESS RELEASE
18 Sep 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208789

FDA
28 May 2020

http://www.pharmatimes.com/news/five_meds_recommended_in_final_2019_chmp_meeting_1320403

Anna Smith PHARMA TIMES
16 Dec 2019

https://insight.rpxcorp.com/litigation_documents/13118803

PATENT LITIGATION
24 Nov 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204702

FDA
08 Nov 2018

https://www.reuters.com/article/us-amerisourcebergn-settlement/amerisourcebergen-to-pay-625-million-in-us-civil-fraud-settlement-idUSKCN1MB3IT

Jonathan Stempel REUTERS
02 Oct 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205648

FDA
21 Sep 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205870

FDA
21 Sep 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206396

FDA
21 Sep 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206416

FDA
21 Sep 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206801

FDA
21 Sep 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207005

FDA
21 Sep 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209287

FDA
21 Sep 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206416

FDA
21 Sep 2018

https://www.pharmacompass.com/pdf/news/jiangsu-yew-pharmaceutical-co-ltd-fails-edqm-inspection-1537438043.pdf

EDQM
15 Sep 2018

https://health.economictimes.indiatimes.com/news/pharma/glenmark-expands-its-oncology-franchise-in-india-with-launch-of-helsinns-akynzeo/64939838

ECONOMIC TIMES
11 Jul 2018

https://www.biospectrumasia.com/news/25/11263/glenmark-launches-helsinns-akynzeo-in-india.html

BIOSPECTRUM
11 Jul 2018

http://www.pharmabiz.com/ArticleDetails.aspx?aid=109921&sid=2

PHARMABIZ
10 Jul 2018

https://globenewswire.com/news-release/2018/06/28/1530972/0/en/Helsinn-Therapeutics-U-S-Inc-becomes-the-exclusive-distributor-of-ALOXI-palonosetron-HCI-in-the-U-S.html

GLOBENEWSWIRE
29 Jun 2018

https://globenewswire.com/news-release/2018/06/28/1530972/0/en/Helsinn-Therapeutics-U-S-Inc-becomes-the-exclusive-distributor-of-ALOXI-palonosetron-HCI-in-the-U-S.html

GLOBENEWSWIRE
28 Jun 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204289

FDA
22 May 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204289

FDA
22 May 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205870

FDA
24 Apr 2018

https://www.thepharmaletter.com/article/glenmark-gets-license-to-market-akynzeo-in-india

THEPHARMALETTER
04 Apr 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=090713

FDA
27 Mar 2018

https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/dr-reddys-launches-generic-nausea-drug-in-us/articleshow/63464361.cms

ECONOMIC TIMES
27 Mar 2018

https://www.businesswire.com/news/home/20180323005590/en/Teva-Announces-Launch-Generic-Version-ALOXI%C2%AE-United

BUSINESSWIRE
23 Mar 2018

https://www.biospectrumasia.com/news/25/10366/mundipharma-acquires-australias-tolmar-adds-eligard-to-its-portfolio.html

BIOSPECTRUM
20 Feb 2018

https://www.pharmacompass.com/pdf/news/lenalidomide-approved-and-3-more-treatments-for-cancer-1514436566.pdf

ANVISA
27 Dec 2017

https://www.manufacturingchemist.com/news/article_page/Patent_battle_for_Aloxi_in_the_US/128833

MANUFACTIRING
04 May 2017

http://www.financialexpress.com/industry/drl-gets-unfavourable-patent-ruling-in-us-court/554719/

FINANCIAL EXPRESS
17 Feb 2017

http://www.biospectrumasia.com/biospectrum/news/224733/mundipharma-expands-oncology-portfolio

BIOSPECTRUM
16 Feb 2017

https://www.pharmacompass.com/pdf/news/teva-pharms-generic-palonosetron-hydrochloride-approved-in-us-1475925665.pdf

06 Oct 2016

http://www.pharma-excipients.ch/2016/10/04/optimization-of-melt-in-mouth-tablets-of-palonosetron-hcl-using-32-full-factorial-design/

PHARMA-EXCIPIENTS
03 Oct 2016

http://www.pharma-excipients.ch/2016/10/04/optimization-of-melt-in-mouth-tablets-of-palonosetron-hcl-using-32-full-factorial-design/

PHARMA-EXCIPIENTS
03 Sep 2016

https://www.pharmacompass.com/pdf/news/exela-pharma-scs-llc-palonosetron-hydrochloride-approved-by-fda-1472292697.pdf

FDA
22 Aug 2016

https://www.pharmacompass.com/pdf/news/accords-palonosetron-receives-market-authorisation-in-the-eu-for-nausea-and-vomiting-caused-by-chemotherapy-1465475521.pdf

EMA
08 Jun 2016

https://www.pharmacompass.com/pdf/news/sandozs-generic-bimatoprost-approved-in-us-for-glaucoma-1461414807.pdf

FDA
19 Apr 2016

http://www.pharmatimes.com/Article/16-04-03/Seven_new_therapies_jump_towards_EU_approval.aspx

Selina McKee PHARMATIMES
04 Apr 2016

http://www.prnewswire.com/news-releases/helsinn-and-eisai-announce-revised-us-collaboration-for-cinv-franchise-300238039.html

PR NEWS WIRE
18 Mar 2016
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