Cingulate Achieves Key Manufacturing Milestone in the Development of its ADHD Drug CTx-1301 in Preparation for FDA Marketing Clearance

Twelve Required Registration Batches Completed New Drug Application Being Prepped for Submission Registration batches are required by the U.S. Food and Drug Administration (FDA) to be manufactured before submitting a new drug application (NDA) using the actual equipment, dosage strengths and procedures that will be used to commercialize the drug product candidate. Cingulate, which recently announced it had received confirmation from and agrees with the FDA on the requirements necessary for filing an NDA for ...