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  • POWDER;INTRAVENOUS - 350MG/VIAL
  • POWDER;INTRAVENOUS - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

https://www.contractpharma.com/contents/view_breaking-news/2024-03-25/olon-celebrates-10-years-of-daptomycin/?widget=listSection

CONTRACT PHARMA
24 Mar 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213966

FDA
07 Aug 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-8-2023-15780.pdf

FDA
08 Mar 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-february-22-2023-51785.pdf

FDA
22 Feb 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-25-2023-68767.pdf

FDA
25 Jan 2023

https://www.prnewswire.com/news-releases/accord-healthcare-inc-issues-nationwide-voluntary-recall-of-daptomycin-for-injection-500-mgvial-and-daptomycin-for-injection-350-mgvial-lot--r2200232-due-to-product-mix-up-301709694.html

PRNEWSWIRE
23 Dec 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216445

FDA
23 Dec 2022

https://endpts.com/blaming-placebo-response-for-uninterpretable-phiii-results-contrafect-calls-for-new-antibiotic-study/

Amber Tong ENDPTS
20 Dec 2022

https://www.globenewswire.com/news-release/2022/10/24/2539639/0/en/ERADICATE-phase-3-study-results-highlight-the-potential-role-of-ceftobiprole-in-the-treatment-of-Staphylococcus-aureus-bacteremia-SAB.html

GLOBENEWSWIRE
24 Oct 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216413

FDA
23 Sep 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215890

FDA
18 Aug 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215215

FDA
26 Nov 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-november-11-2021-1636538960.pdf

FDA
10 Nov 2021

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/merck-issues-voluntary-nationwide-recall-cubicinr-daptomycin-injection-500-mg-lot-934778-due

PRESS RELEASE
21 Oct 2021

https://www.businesswire.com/news/home/20211019006241/en

BUSINESSWIRE
19 Oct 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213171

FDA
02 Sep 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213623

FDA
30 Jun 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213623

FDA
29 Jun 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212250

FDA
04 May 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211403

FDA
02 Sep 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213425

FDA
20 Aug 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-12-2020-1597212134.pdf

FDA
12 Aug 2020

https://www.fiercepharma.com/manufacturing/mylan-pulls-single-daptomycin-lot-after-particulates-found

Fraiser Kansteiner FIERCE PHARMA
09 Jul 2020

https://www.pharmacompass.com/pdf/news/mylan-initiates-voluntary-nationwide-recall-of-one-lot-of-daptomycin-for-injection-1594181456.pdf

FDA
08 Jul 2020

https://www.prnewswire.com/news-releases/sandoz-acquires-us-distribution-rights-to-two-key-hospital-injectable-medicines-reinforcing-strategic-focus-on-key-growth-segment-301028154.html

PR NEWSWIRE
23 Mar 2020

https://www.moneycontrol.com/news/business/cipla-launches-skin-treatment-drug-in-us-4476041.html

MONEYCONTROL
26 Sep 2019

https://www.prnewswire.com/news-releases/cipla-announces-the-launch-of-daptomycin-for-injection-500-mgvial-single-dose-vials-for-intravenous-use-only-300925849.html

PR NEWSWIRE
26 Sep 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212022

FDA
27 Aug 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212667

FDA
12 Jul 2019

https://www.in-pharmatechnologist.com/Article/2019/07/02/Xellia-moves-production-of-anti-infectives-to-its-distribution-hub

Maggie Lynch IN PHARMATECHNOLOGIST
02 Jul 2019

https://www.biospace.com/article/research-roundup-deeper-understanding-of-alzheimer-s-and-more/

Mark Terry BIOSPACE
28 Jun 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212513

FDA
26 Jun 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211961

FDA
24 Jun 2019

https://www.fiercepharma.com/pharma/merck-scores-zerbaxa-label-expansion-years-after-cubist-buyout

Eric Sagonowsky FIERCE PHARMA
05 Jun 2019

https://www.businesswire.com/news/home/20190514006143/en/Dr.-Reddys-Laboratories-announces-launch-Daptomycin-Injection

BUSINESSWIRE
14 May 2019

https://www.pharmacompass.com/pdf/news/anvisa-registers-new-generic-drugs-1548929482.pdf

ANVISA
30 Jan 2019

https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/UCM293268.pdf

FDA
01 Nov 2018

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-challenge-of-cubicin-rf-21572-daptomycin-for-injection-1541062844.pdf

FDA
01 Nov 2018

https://www.ema.europa.eu/documents/regulatory-procedural-guideline/list-centrally-authorised-products-requiring-notification-change-update-annexes_en-0.pdf

EMA
12 Oct 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-8-2018-1533711950.pdf

FDA
08 Aug 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205037

FDA
07 Jun 2018

https://www.businesswire.com/news/home/20180412006181/en

BUSINESSWIRE
13 Apr 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206077

FDA
13 Apr 2018

https://www.pharmacompass.com/pdf/news/hospira-uk-limited-daptomycin-hospira-daptomycin-receives-approval-in-europe-1493097545.pdf

EMA
25 Apr 2017

http://www.fiercepharma.com/pharma/merck-falls-short-q4-sales-but-sees-eps-growth-ahead

Eric Sagonowsky FIERCE PHARMA
02 Feb 2017

http://www.pharmatimes.com/news/eight_medicines_leap_towards_eu_approval_1185408

Selina McKee PHARMATIMES
30 Jan 2017

http://www.fiercepharma.com/pharma/generics-set-to-undercut-blockbusters-from-merck-novartis-bms-2017

Eric Sagonowsky FIERCE PHARMA
18 Jan 2017

http://www.pharmabiz.com/NewsDetails.aspx?aid=97526&sid=2

PHARMABIZ
16 Sep 2016

https://www.pharmacompass.com/pdf/news/crane-pharmaceuticals-generic-daptomycin-approved-in-us-1466247067.pdf

FDA
15 Jun 2016

https://www.pharmacompass.com/pdf/news/us-fda-enforcement-report-8june2016-1465388450.pdf

FDA
08 Jun 2016
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