In alignment with U.S. Food and Drug Administration requirements, Cingulate has completed the manufacturing of its twelve registration batches for its lead asset CTx-1301 for the treatment of Attention Deficit Hyperactivity Disorder. Registration batches are required by the U.S. Food and Drug Administration to be manufactured before submitting a new drug application 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 CTx-1301, has begun NDA preparation and expects to submit its application in the first half of 2025.
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