New Drug Application Acceptance Archives

U.S. FDA Accepts AbbVie’s New Drug Application for Atogepant for the Preventive Treatment of Migraine

Calcitonin Gene-Related Peptide (CGRP) Inhibitors, Clinical Trials, Episodic Migraine, FDA, Migraine, New Drug Application Acceptance, New Drug Applications, R&D, Secondary Endpoints

The U.S. Food and Drug Administration accepted AbbVie’s New Drug Application for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist for the preventive treatment of migraine in adults who meet criteria for episodic migraine.

FDA Accepts NDA for Aquestive’s Libervant for Seizures

Anti-Epileptic Drugs (AEDs), Buccal Film, Epilepsy, FDA, FDA/Regulatory, New Drug Application Acceptance, Seizure Clusters

The U.S. Food and Drug Administration accepted Aquestive Therapeutics’ New Drug Application for Libervant (diazepam) Buccal Film for seizure clusters.

FDA Accepts New Drug Application for RedHill’s Talicia

Biopharmaceutical, Fast Track Designation, FDA, FDA/Regulatory, H. pylori infection, Market exclusivity, New Drug Application Acceptance, Priority Review

RedHill Biopharma Ltd. announced that the U.S. Food and Drug Administration accepted for review the New Drug Application for Talicia (RHB-105) for H. pylori infection.