lamotrigine oral suspension (ET-105) / Eton Pharma, Aucta Pharma, Azurity Pharma - LARVOL DELTA

Analyse des données de surveillance des décès maternels de la région ME, Côte d'Ivoire, Janvier 2020 à Décembre 2023. (PubMed, J Epidemiol Popul Health) - "Pour la gestion de la qualité des données, la complétude acceptable est supérieure à 95% et la concordance acceptable est celle comprise entre 95% et 105%...La majorité des décès surviennent dans la nuit. Le ratio de mortalité maternelle dans la région ME est élevé."

Journal

U.S. FDA declines to approve Eton Pharma's anti-seizure drug (Reuters) - "Eton Pharmaceuticals Inc...said on Friday the U.S. Food and Drug Administration declined to approve its anti-seizure drug lamotrigine, sending the drugmaker's shares down 13% in extended trading....The drugmaker did not disclose the details of the complete response letter and added that it was assessing the FDA's comments along with its partner."

FDA event • CNS Disorders • Epilepsy

Administration of Lamotrigine Formulation for Oral Suspension (ET-105) Through Gastrostomy Feeding Tubes (AAN 2020) - "ET-105, lamotrigine for oral suspension, can be delivered accurately through g-tubes down to at least a minimum diameter of 0.8 cm/12 Fr."

CNS Disorders • Epilepsy

Safety, Tolerability, and Pharmacokinetics of ET-105, Lamotrigine for Oral Suspension, Under Fasting and Fed Conditions (AAN 2020) - "The administration of ET-105, lamotrigine for oral suspension, was safe and well tolerated in healthy subjects under fasting and fed conditions and is bioequivalent to reference lamotrigine tablets."

Clinical • PK/PD data • CNS Disorders • Epilepsy