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  • INJECTABLE;INJECTION - 200MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE;INJECTION - 400MG/200ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • INJECTABLE, SUSPENSION;OTIC - 6% (60MG/ML)
  • SUSPENSION/DROPS;OTIC - 0.3%;0.1%

https://www.businesswire.com/news/home/20240325695019/en

BUSINESSWIRE
25 Mar 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215768

FDA
09 Jun 2023

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

FDA
25 Jan 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210470

FDA
30 Aug 2022

https://www.fiercebiotech.com/biotech/iterum-will-give-uti-antibiotic-another-go-new-trial-after-meeting-fda

K. LaHucik FIERCEBIOTECH
30 Sep 2021

https://www.biospace.com/article/releases/alk-acquires-otiprio-ciprofloxacin-otic-suspension-broadening-treatment-solutions-for-healthcare-providers-and-patients/?s=79

BIOSPACE
03 Jun 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205548

FDA
13 Aug 2020

https://www.prnewswire.com/news-releases/alk-enters-into-co-promotion-agreement-with-otonomy-for-otiprio-ciprofloxacin-otic-suspension-the-first-and-only-single-dose-treatment-for-acute-otitis-externa-swimmers-ear-301078800.html

PR NEWSWIRE
17 Jun 2020

https://www.businesswire.com/news/home/20200527005192/en

BUSINESSWIRE
27 May 2020

https://www.businesswire.com/news/home/20200430005198/en/Aradigm-Announces-Conditional-Approval-Combined-Chapter-11

BUSINESSWIRE
30 Apr 2020

https://www.fiercepharma.com/manufacturing/india-hoping-to-challenge-chinese-dominance-plans-drug-ingredient-production-push

FIERCE PHARMA
16 Apr 2020

https://www.biospace.com/article/releases/aradigm-announces-sale-of-assets-to-grifols-s-a-/?s=79

BIOSPACE
06 Apr 2020

https://www.businesswire.com/news/home/20200403005486/en/Aradigm-Announces-Sale-Assets-Grifols-S.A.

BUSINESSWIRE
03 Apr 2020

https://www.businesswire.com/news/home/20200402005492/en/Savara-Obtains-Global-Rights-Develop-Commercialize-Apulmiq

BUSINESSWIRE
02 Apr 2020

https://endpts.com/bankrupt-antibiotics-maker-aradigm-turns-to-old-partner-investor-for-final-3m-fire-sale/

Amber Tong ENDPTS
21 Feb 2020

https://endpts.com/with-looming-superbug-crisis-iterum-misses-in-a-key-antibiotic-trial-and-its-shares-tumble/

Natalie Grover ENDPTS
11 Dec 2019

https://economictimes.indiatimes.com/industry/healthcare/biotech/healthcare/antibiotic-resistance-in-food-animals-growing/articleshow/71213015.cms

Malathy Iyer THE ECONOMIC TIMES
20 Sep 2019

https://www.pharmacompass.com/pdf/news/akorn-inc-receives-fda-warning-letter-1562734261.pdf

FDA
09 Jul 2019

https://www.in-pharmatechnologist.com/Article/2019/05/30/EMA-calls-on-pharma-to-create-stronger-antibiotics

Vassia Barba IN-PHARMATECHNOLGY
30 May 2019

https://www.moneycontrol.com/news/business/glenmark-therapeutics-inks-pact-with-otonomy-to-promote-otiprio-in-us-3928061.html

MONEYCONTROL
03 May 2019

https://www.nbcnews.com/health/health-news/fda-warns-some-antibiotics-can-cause-serious-heart-damage-n950606

Maggie Fox NBC NEWS
22 Dec 2018

https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-24605.pdf

FDA
08 Nov 2018

http://svt.com/en/laboratorios-salvat-completes-patient-recruitment-for-the-ciflotex-trial-2/

PRESS RELEASE
12 Sep 2018

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2018/67550r-eng.php

HEALTH CANADA
20 Aug 2018

https://health.economictimes.indiatimes.com/news/pharma/commonly-used-antibiotic-in-india-under-usfda-lens/64958016

Sushmi Dey ECONOMIC TIMES
13 Jul 2018

http://www.pharmabiz.com/NewsDetails.aspx?aid=109959&sid=1

Arun Sreenivasan
13 Jul 2018

http://www.pharmabiz.com/NewsDetails.aspx?aid=109928&sid=2

PHARMABIZ
11 Jul 2018

https://www.medpagetoday.com/infectiousdisease/generalinfectiousdisease/73954

Molly Walker MED PAGE TODAY
11 Jul 2018

https://www.businesswire.com/news/home/20180405005412/en/Aradigm-Announces-EMA-Completed-Validation-MAA-Submission

BUSINESSWIRE
06 Apr 2018

https://www.in-pharmatechnologist.com/Article/2018/02/01/US-FDA-serves-Aradigm-CRL-Phase-III-data-wanted

Flora Southey IN PHARMATECHNOLOGIST
02 Feb 2018

https://www.biospace.com/article/releases/fda-formally-rejects-aradigm-s-linhaliq-requests-a-new-phase-iii-trial-for-reconsideration/

John Carroll ENDPTS
30 Jan 2018

http://www.pmlive.com/pharma_news/fda_panel_rejects_aradigmgrifols_inhaled_antibiotic_1216827

Phil Taylor PMLIVE
12 Jan 2018

https://www.fiercebiotech.com/biotech/aradigm-crashes-after-fda-panel-votes-down-antibiotic

Nick P. Taylor FIERCE BIOTECH
12 Jan 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-december-27-2017-1514352313.pdf

FDA
27 Dec 2017

https://www.fiercepharma.com/manufacturing/bluebird-buys-manufacturing-site-to-produce-viral-vector-as-it-advances-gene

Eric Palmer FIERCE PHARMA
29 Nov 2017

http://www.pharmabiz.com/NewsDetails.aspx?aid=105773&sid=2

PHARMABIZ
29 Nov 2017

http://pharmabiz.com/ArticleDetails.aspx?aid=102249&sid=1

PHARMABIZ
30 May 2017

http://svt.com/en/pediapharm-announces-the-commercial-launch-of-otixal-in-canada/

PRESS RELEASE
18 May 2017

https://www.pharmacompass.com/pdf/news/Enforcement-Report-Week-of-April-5-2017-1491371454.pdf

FDA
05 Apr 2017

http://www.fiercebiotech.com/biotech/otonomy-close-to-filing-otiprio-for-swimmer-s-ear

Phil Taylor FIERCE BIOTECH
06 Jan 2017

http://economictimes.indiatimes.com/articleshow/54986424.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst

Prabha Raghavan ECONOMIC TIMES
21 Oct 2016

https://www.pharmacompass.com/pdf/news/anvisa-suspended-14-medicines-cosmetics-1474371919.pdf

ANVISA
19 Sep 2016

http://www.prnewswire.com/news-releases/laboratorios-salvat-sa-and-arbor-pharmaceuticals-llc-announce-the-launch-of-otovel-ciprofloxacin-03--and-fluocinolone-acetonide-0025--otic-solution-300319434.html

PR NEWSWIRE
29 Aug 2016

https://www.pharmacompass.com/pdf/news/laboratorios-salvats-otovel-ciprofloxacinfluocinolone-acetonide-approved-in-us-for-bacterial-infections-1462268989.pdf

FDA
29 Apr 2016

http://www.in-pharmatechnologist.com/Regulatory-Safety/Ciproflaxin-resistance-spreading-says-taskforce-calling-on-drug-industry-for-new-antibiotics

Phil Hoad IN PHARMATECHNOLOGIST
22 Feb 2016

http://www.forbes.com/sites/judystone/2016/02/13/news-about-superbugs-resistant-to-all-antibiotics-worsens/?ss=pharma-healthcare#33036b454cdd

Judy Stone FORBES
13 Feb 2016

http://www.prnewswire.com/news-releases/salvat-and-lees-pharmaceutical-hk-limited-announce-exclusive-license-and-supply-agreement-for-duoxal-in-greater-china-564981691.html

PR NEWS WIRE
11 Jan 2016

https://www.pharmacompass.com/pdf/news/otonomy-incs-otiprio-approve-in-us-as-broad-spectrum-antimicrobial-agents-1449908510.pdf

FDA
10 Dec 2015

http://portal.anvisa.gov.br/wps/content/anvisa+portal/anvisa/sala+de+imprensa/menu+-+noticias+anos/2015/anvisa+suspende+lote+de+cloridrato+de+ciprofloxacino+da+empresa+prati-donaduzzi

ANVISA
20 Jun 2015

http://www.pharmabiz.com/NewsDetails.aspx?aid=88519&sid=1

Ramesh Shankar PHARMABIZ.COM
26 May 2015
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