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  • INJECTABLE;INTRATHECAL - 0.05MG/ML
  • INJECTABLE;INTRATHECAL - 0.5MG/ML
  • INJECTABLE;INTRATHECAL - 1MG/ML
  • INJECTABLE;INTRATHECAL - 2MG/ML

https://www.globenewswire.com/news-release/2024/04/09/2859816/0/en/ANI-Pharmaceuticals-Announces-the-Launch-of-Baclofen-Oral-Suspension.html

GLOBENEWSWIRE
09 Apr 2024

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217788

FDA
10 Jan 2024

https://www.prnewswire.com/news-releases/allos-pharma-inc-expands-intellectual-property-rights-for-arbaclofen-301930753.html

PR NEWSWIRE
18 Sep 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216309

FDA
10 Aug 2023

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217252

FDA
08 Jun 2023

https://www.globenewswire.com/news-release/2023/05/22/2673311/0/en/Rhythm-Pharmaceuticals-and-Genpharm-Announce-Collaboration-to-Provide-IMCIVREE-setmelanotide-to-Patients-in-Gulf-Cooperation-Council-Countries.html

GLOBENEWSWIRE
22 May 2023

https://www.pharmacompass.com/pdf/news/fda-confirms-paragraph-iv-patent-litigation-for-baclofen-1656568460.pdf

FDA
28 Jun 2022

https://www.businesswire.com/news/home/20220601005309/en

BUSINESSWIRE
01 Jun 2022

http://www.pharmabiz.com/NewsDetails.aspx?aid=145683&sid=2

PHARMABIZ
08 Feb 2022

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215885

FDA
25 Jan 2022

https://www.businesswire.com/news/home/20220104005935/en

BUSINESSWIRE
05 Jan 2022

https://www.karthapharmaceuticals.com/news

PRESS RELEASE
21 Dec 2021

https://www.globenewswire.com/news-release/2021/08/18/2282387/0/en/Albireo-and-Genpharm-Announce-Agreement-to-Commercialize-Bylvay-odevixibat-in-Saudi-Arabia-and-the-Gulf-Region.html

GLOBENEWSWIRE
18 Aug 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-18-2021-1629274448.pdf

FDA
18 Aug 2021

https://drugstorenews.com/beximco-receives-fda-nod-baclofen#:~:text=Beximco%20has%20received%20the%20Food,spinal%20cord%20injury%20or%20disease.

DRUGSTORENEWS
26 Jul 2021

https://drugstorenews.com/beximco-receives-fda-nod-baclofen#:~:text=Beximco%20has%20received%20the%20Food,spinal%20cord%20injury%20or%20disease.

DRUGSTORENEWS
26 Jul 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214099

FDA
13 Jul 2021

https://lawstreetmedia.com/news/health/research-co-says-competitor-misappropriated-trade-secrets-in-development-of-baclofen/

PRESS RELEASE
31 Mar 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210777

FDA
21 Jan 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212378

FDA
14 Oct 2020

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=212067

FDA
16 Jul 2020

http://pharmabiz.com/NewsDetails.aspx?aid=129546&sid=2

PHARMABIZ
13 Jul 2020

https://www.indiainfoline.com/article/news-top-story/unichem-lab-gets-usfda-nod-for-baclofen-tablets-stock-ends-higher-120071000527_1.html

INDIAINFOLINE
10 Jul 2020

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-7-2019-1565155577.pdf

FDA
07 Aug 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210315

FDA
02 Aug 2019

https://www.raps.org/news-and-articles/news-articles/2019/7/fda-sends-warning-letters-to-aurobindo-api-repack?feed=Regulatory-Focus

Michael Mezher RAPS
03 Jul 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211555

FDA
01 Feb 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211659

FDA
27 Nov 2018

https://www.biospace.com/article/osmotica-pharmaceuticals-plc-announces-pricing-of-initial-public-offering/

BIOSPACE
17 Oct 2018

https://seekingalpha.com/article/4207220-osmotica-pharmaceuticals-files-raise-capital-u-s-ipo?source=partner_newsnow

Donovan Jones SEEKING ALPHA
19 Sep 2018

https://www.pharmacompass.com/pdf/news/peoples-custom-rx-sterile-drug-producer-receives-fda-form-483-1536902931.pdf

FDA
13 Sep 2018

https://www.prnewswire.com/news-releases/novaquest-capital-management-acquires-cutispharma-inc-300619121.html

PRNEWSWIRE
26 Mar 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209592

FDA
23 Mar 2018

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209102

FDA
29 Nov 2017

http://www.moneycontrol.com/news/business/stocks-business/morgan-stanley-underweight-on-sun-pharma-sparcs-baclofen-grs-fails-in-phase-iii-study-2407883.html

MONEYCONTROL
10 Oct 2017

http://www.livescience.com/41517-cyclobenzaprine.html

Elaine J. Hom LIVE SCIENCE
11 May 2017

http://www.fiercebiotech.com/biotech/galapagos-pharnext-join-forces-to-develop-drug-combos

NP Taylor FIERCE BIOTECH
11 Mar 2017

http://www.prnewswire.com/news-releases/teligent-inc-announces-health-canada-approval-of-three-baclofen-injection-products-300318097.html

PR NEWSWIRE
25 Aug 2016

https://www.pharmacompass.com/pdf/news/sinteticas-generic-baclofen-approved-in-us-as-muscle-relaxer-antispastic-agent-1462535005.pdf

FDA
03 May 2016

https://www.pharmacompass.com/pdf/news/us-fda-enforcement-report-16mar2016-1458126358.pdf

FDA
16 Mar 2016

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0733-2016&w=03092016&lang=eng

FDA
09 Mar 2016

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0569-2016&w=01272016&lang=eng

FDA
27 Jan 2016

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0570-2016&w=01272016&lang=eng

FDA
27 Jan 2016

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=D-0573-2016&w=01272016&lang=eng

FDA
27 Jan 2016

http://health.economictimes.indiatimes.com/news/pharma/french-drug-developer-pharnext-to-take-rare-approach-to-pricing/50200904

Natalie Grover ET HEALTHWORLD
17 Dec 2015

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm476514.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

FDA
09 Dec 2015

http://portal.anvisa.gov.br/wps/content/anvisa+portal/anvisa/sala+de+imprensa/menu+-+noticias+anos/2015/anvisa+suspende+lotes+de+medicamentos+da+uniao+quimica

ANVISA
04 Nov 2015

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

Eric Palmer FIERCE PHARMA MFG
02 May 2015
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