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  • CAPSULE;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SYRUP;ORAL - 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, DELAYED RELEASE;ORAL - EQ 125MG VALPROIC ACID
  • TABLET, DELAYED RELEASE;ORAL - EQ 250MG VALPROIC ACID
  • TABLET, DELAYED RELEASE;ORAL - EQ 500MG VALPROIC ACID
  • CAPSULE, DELAYED REL PELLETS;ORAL - EQ 125MG VALPROIC ACID
  • TABLET, EXTENDED RELEASE;ORAL - EQ 250MG VALPROIC ACID
  • TABLET, EXTENDED RELEASE;ORAL - EQ 500MG VALPROIC ACID

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-april-3-2024-41763.pdf

FDA
03 Apr 2024

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-june-7-2023-80553.pdf

FDA
07 Jun 2023

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-31-2022-1661930463.pdf

FDA
31 Aug 2022

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-3-2022-1659944441.pdf

FDA
03 Aug 2022

https://health.economictimes.indiatimes.com/news/pharma/sanofi-ordered-to-compensate-french-family-for-epilepsy-drug-side-effects/91592795

ET HEALTH
17 May 2022

https://www.expresspharma.in/unichem-laboratories-receives-us-fda-approval-for-divalproex-sodium/

EXPRESSPHARMA
01 Mar 2022

https://www.reuters.com/business/healthcare-pharmaceuticals/french-court-rules-favour-class-action-against-sanofi-over-depakine-drug-media-2022-01-05/

Tangi Salaun REUTERS
06 Jan 2022

http://www.pharmafile.com/news/600699/fda-approves-bipolar-depression-treatment-broad-range-adults

PHARMAFILE
21 Dec 2021

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-october-6-2021-1633509984.pdf

FDA
06 Oct 2021

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

FDA
29 Sep 2021

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=214462

FDA
23 Mar 2021

https://endpts.com/french-health-products-agency-yanked-into-legal-battle-over-birth-defects-caused-by-sanofis-depakine/

Nicole DeFeudis ENDPTS
13 Nov 2020

https://www.fiercepharma.com/marketing/intra-cellular-s-caplyta-could-cruise-toward-blockbuster-land-bipolar-depression-win

Angus Liu FIERCE PHARMA
09 Sep 2020

https://seekingalpha.com/news/3612432-intra-cellularsplus-74-on-positive-lumateperone-data-in-bipolar-patients

M. Mayani SEEKINGALPHA
08 Sep 2020

https://endpts.com/sanofi-under-formal-investigation-for-depakine-allegations-beam-licenses-car-t-tech-from-oxford-biomedica/

N. DeFeudis ENDPTS
04 Aug 2020

https://www.gov.uk/drug-safety-update/valproate-pregnancy-prevention-programme-temporary-advice-for-management-during-coronavirus-covid-19

GOVUK
21 May 2020

https://www.gov.uk/drug-safety-update/valproate-epilim-depakote-pregnancy-prevention-programme-updated-educational-materials

GOVUK
13 Feb 2020

https://www.fiercepharma.com/pharma/sanofi-facing-french-charges-depakine-birth-defects-probe

K.Blankenship FIERCE PHARMA
05 Feb 2020

https://endpts.com/too-slow-to-warn-sanofi-indicted-over-old-anti-epileptic-drug-tied-to-birth-defects-reports/

N. Grover ENDPTS
05 Feb 2020

https://www.gov.uk/guidance/valproate-use-by-women-and-girls

GOVUK
19 Dec 2019

http://www.pharmabiz.com/NewsDetails.aspx?aid=118899&sid=2

PHARMABIZ
21 Oct 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209286

FDA
19 Oct 2019

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207611

FDA
08 Aug 2019

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

FDA
07 Aug 2019

https://www.business-standard.com/article/pti-stories/dr-reddy-s-cipla-arm-recall-drugs-in-us-market-119042800224_1.html

BUSINESS-STANDARD
29 Apr 2019

https://www.business-standard.com/article/companies/dr-reddy-s-recalls-anti-seizure-drug-in-the-us-market-119042600538_1.html

BUSINESS-STANDARD
26 Apr 2019

https://www.pharmacompass.com/pdf/news/Enforcement-Report-Week-of-April-24-2019-1556080066.pdf

FDA
24 Apr 2019

https://www.gov.uk/guidance/valproate-use-by-women-and-girls

GOVUK
09 Apr 2019

https://www.pharmacompass.com/pdf/news/Enforcement-Report-Week-of-February-27-2019-1551242597.pdf

FDA
27 Feb 2019

https://www.biospace.com/article/political-battle-over-fetal-tissue-could-force-closure-of-research-center-pivotal-to-hiv-therapies/

Alex Keown BIOSPACE
06 Dec 2018

https://www.ema.europa.eu/documents/psusa-conclusions/valproic-acid-sodium-valproate-valproate-pivoxil-valproate-semisodium-valpromide-cmdh-scientific/00003090/201801_en.pdf

EMA
25 Oct 2018

https://www.ema.europa.eu/documents/psusa-products/valproic-acid-sodium-valproate-valproate-pivoxil-valproate-semisodium-valpromide-valproate-bismuth/00003090/201801_en.pdf

EMA
25 Oct 2018

https://www.reuters.com/article/us-sanofi-epilepsy/uk-bans-sanofi-epilepsy-drug-without-pregnancy-prevention-plan-idUSKBN1HV0RY

Ben Hirschler REUTERS
25 Apr 2018

http://www.pharmatimes.com/news/mhra_bans_valproate_without_pregnancy_prevention_programme_1233022

Selina McKee PHARMA TIMES
24 Apr 2018

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/03/news_detail_002929.jsp&mid=WC0b01ac058004d5c1

EMA
23 Mar 2018

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/02/news_detail_002903.jsp&mid=WC0b01ac058004d5c1

EMA
09 Feb 2018

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-january-24-2018-1516779005.pdf

FDA
24 Jan 2018

https://www.pharmacompass.com/pdf/news/gathering-medicines-diprivan-and-depakote-1515654959.pdf

FDA
11 Jan 2018

http://uk.reuters.com/article/us-sanofi-epilepsy/pregnant-women-still-unaware-of-epilepsy-drug-risks-ema-hearing-idUKKCN1C12MD?rpc=401&

M. Blamont REUTERS
27 Sep 2017

https://www.law360.com/lifesciences/articles/963626

Daniel Siegal LAW360
14 Sep 2017

https://www.biospectrumasia.com/news/33/9370/generic-seroquel-xr-tablets-launched-by-lupin-in-usa.html

BIOSPECTRUM
24 Aug 2017

https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-9-2017-1502256126.pdf

FDA
09 Aug 2017

http://www.nasdaq.com/article/abbvie-must-pay-15-mln-in-depakote-birthdefect-trial-jury-20170609-00770

Nate Raymond NASDAQ
10 Jun 2017

http://www.raps.org/Regulatory-Focus/News/2017/06/09/27876/EMA%E2%80%99s-PRAC%C2%A0to-Hold-First-Public-Hearing-on-Use-of-Valproate-Medicines/?utm_source=Email&utm_medium=Informz&utm_campaign=Informz-Emails

Zachary Brennan RAPS
09 Jun 2017

http://www.biospace.com/News/up-to-4100-children-victims-of-sanofis-epilepsy/453156/source=TopBreaking?intcid=homepage-seekernewssection-tabtopbreakingnews

Alex Keown BIOSPACE
21 Apr 2017

http://www.pharmamanufacturing.com/industrynews/2017/sanofi-epilepsy-drug-causes-birth-defects/

PHARMA MANUFACTURING
20 Apr 2017

http://www.bbc.com/news/world-europe-39657139

BBC
20 Apr 2017

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substances/human_referral_prac_000066.jsp&mid=WC0b01ac05805c516f

EMA
11 Apr 2017

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

FDA
05 Apr 2017

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/referrals/Valproate_and_related_substances/human_referral_prac_000066.jsp&mid=WC0b01ac05805c516f

EMA
17 Mar 2017
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