Enforcement Report - Week of April 3, 2024
03 Apr 2024 //
FDA
Enforcement Report - Week of June 7, 2023
07 Jun 2023 //
FDA
Enforcement Report - Week of August 31, 2022
31 Aug 2022 //
FDA
Enforcement Report - Week of August 3, 2022
03 Aug 2022 //
FDA
Sanofi ordered to compensate French family for epilepsy drug side effects
17 May 2022 //
ET HEALTH
Unichem Laboratories receives US FDA approval for divalproex sodium
01 Mar 2022 //
EXPRESSPHARMA
French court backs class action against Sanofi over Depakine drug
06 Jan 2022 //
REUTERS
FDA approves bipolar depression treatment for broad range of adults
21 Dec 2021 //
PHARMAFILE
Enforcement Report - Week of October 6, 2021
06 Oct 2021 //
FDA
Enforcement Report - Week of September 29, 2021
29 Sep 2021 //
FDA
AMTA`s Generic Divalproex Sodium Receives Approval In US
23 Mar 2021 //
FDA
Intra-Cellular`s Caplyta could cruise toward bipolar depression win
09 Sep 2020 //
FIERCE PHARMA
Intra-Cellular`s +74% on positive lumateperone data in bipolar patients
08 Sep 2020 //
SEEKINGALPHA
Valproate Pregnancy Prevention Programme: temporary coronavirus (COVID-19)
21 May 2020 //
GOVUK
Valproate (Epilim, Depakote) pregnancy prevention programme
13 Feb 2020 //
GOVUK
Sanofi indicted over old anti-epileptic drug tied to birth defects
05 Feb 2020 //
ENDPTS
Sanofi faces French charges in Depakine birth defects probe
05 Feb 2020 //
FIERCE PHARMA
Valproate use by women and girls
19 Dec 2019 //
GOVUK
Lupin gets US FDA marketing approval for divalproex sodium
21 Oct 2019 //
PHARMABIZ
Lupin Ltd`s Generic Divalproex Sodium Receives Approval In US
19 Oct 2019 //
FDA
Novelgenix Theraps` Generic Valproic Acid Receives Approval in US
08 Aug 2019 //
FDA
Enforcement Report - Week of August 7, 2019
07 Aug 2019 //
FDA
Dr Reddy`s Laboratories, Cipla arm recall drugs from American market
29 Apr 2019 //
BUSINESS-STANDARD
Dr Reddy`s recalls anti-seizure drug in the US market
26 Apr 2019 //
BUSINESS-STANDARD
Enforcement Report - Week of April 24, 2019
24 Apr 2019 //
FDA
Valproate use by women and girls
09 Apr 2019 //
GOVUK
Enforcement Report - Week of February 27, 2019
27 Feb 2019 //
FDA
Political Battle Over Fetal Tissue Could Force Closure of Research Center
06 Dec 2018 //
BIOSPACE
Valproic Acid - List of nationally authorised medicinal products in Europe
25 Oct 2018 //
EMA
Valproic Acid - Scientific conclusions and new Authorisation terms in Europe
25 Oct 2018 //
EMA
UK bans Sanofi epilepsy drug without pregnancy prevention plan
25 Apr 2018 //
REUTERS
MHRA bans valproate without pregnancy prevention programme
24 Apr 2018 //
PHARMA TIMES
New measures to avoid valproate exposure in pregnancy endorsed
23 Mar 2018 //
EMA
PRAC recommends new measures to avoid valproate exposure in pregnancy
09 Feb 2018 //
EMA
Enforcement Report - Week of January 24, 2018
24 Jan 2018 //
FDA
Gathering: Medicines Diprivan and Depakote
11 Jan 2018 //
FDA
Pregnant women still unaware of epilepsy drug risks: EMA hearing
27 Sep 2017 //
REUTERS
Abbott Must Pay $38M Depakote Verdict, Mo. High Court Says
14 Sep 2017 //
LAW360
Generic Seroquel XR tablets launched by Lupin in USA
24 Aug 2017 //
BIOSPECTRUM
Enforcement Report - Week of August 9, 2017
09 Aug 2017 //
FDA
AbbVie must pay $15 mln in Depakote birth-defect trial: jury
10 Jun 2017 //
NASDAQ
EMA’s PRAC to Hold First Public Hearing on Use of Valproate Medicines
09 Jun 2017 //
RAPS
Up to 4,100 Children Victims of Sanofi Epilepsy Drug, Says French Regulator
21 Apr 2017 //
BIOSPACE
New evidence in France of harm from epilepsy drug valproate
20 Apr 2017 //
BBC
Sanofi Epilepsy Drug Linked to Birth Defects
20 Apr 2017 //
PHARMA MANUFACTURING
New review of valproate use in pregnancy and women of childbearing age
11 Apr 2017 //
EMA
Enforcement Report - Week of April 5, 2017
05 Apr 2017 //
FDA
Review of valproate use in pregnancy and women of childbearing age
17 Mar 2017 //
EMA
Sobi & Horizon enter five-year distribution agreement for Ravicti & Ammonaps
07 Dec 2016 //
PR NEWSWIRE
France sets up fund for Sanofi epilepsy drug victims
16 Nov 2016 //
REUTERS
Hillary Clinton win may pose pricing challenges for Indian pharma companies
07 Nov 2016 //
ECONOMIC TIMES
Sanofi will accept epilepsy drug blame if court rules that way
29 Oct 2016 //
REUTERS
Thousands of women took Sanofi epilepsy drug despite risk to fetuses: media
10 Aug 2016 //
REUTERS
Catalent plant gets 14 observations from FDA
21 Apr 2016 //
FIERCE PHARMA MFG
Divalproex Sodium Market Outlook to 2020 for Global, China and India Regions
09 Oct 2015 //
PR NEWSWIRE
Dr Reddy`s Laboratories recalls anti-seizure, hypertension drugs from US market
29 Jun 2015 //
THE ECONOMIC TIMES
Israel Firm To Develop Epilepsy Drug In China
15 Apr 2015 //
BIOSPECTRUM
Report Card: FDA Earns a Solid
25 Jan 2015 //
FDA LAW BLOG