The CRL comes after the FDA accepted the NDA for review in October 2025 and set a Prescription Drug User Fee Act target ...
FDA’s CRL focused on CMC deficiencies, with no objections to clinical safety or efficacy, enabling a resubmission pathway primarily driven by manufacturing remediation. The NDA was accepted in October ...
The FDA issued a complete response letter for Cingulate's ADHD drug CTx-1301 citing manufacturing data requests, with no ...
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