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The National Agency for Medicines and Health Products in France has been indicted for “injuries and manslaughter through negligence” in connection with the availability of a Sanofi (SNY) epilepsy drug that has been linked to more than 400 congenital birth defects or stillborn births.

The indictment, which the regulator disclosed in a brief statement, is the latest development in a tumultuous scandal over the medicine, known as Depakine in France. Last August, the drug maker was indicted by French authorities for causing harm and failing to inform the public about the risks of taking the treatment during pregnancy.


Four years ago, prosecutors launched a preliminary investigation into the authorization and marketing of Depakine after IGAS, France’s social affairs inspection agency, criticized the slow response by Sanofi and the regulator, which is known as ANSM. The disclosure prompted families around France to file a class-action lawsuit against the drug maker.

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