Cingulate Receives Formal Pre-NDA Meeting Minutes From FDA For CTx-1301 In ADHD
Benzinga Newsdesk 1 year ago
NewsFDA
Details of the FDA's minutes include the following, all of which will be a matter of review during the approval process:The agency agreed to a post-NDA approval commitment of additional stability date for the 6
Details of the FDA's minutes include the following, all of which will be a matter of review during the approval process:
- The agency agreed to a post-NDA approval commitment of additional stability date for the 6 intermediate dose strengths of 12.5-mg, 18.75-mg, 25-mg, 31.25-mg, 37.5-mg, and 43.75-mg.
- Cingulate expects shelf-life for all dosage strengths to be 24 months at launch, the results from the aforementioned batches may allow the shelf-life to be extended.
- Available data for nonclinical safety appears adequate to support a filing.
- With a scientific bridge established upon review, CTx-1301 may rely on the efficacy and safety data of the listed drug, Focalin XR.
- Cingulate's proposed approach to the integrated safety summary (ISS) and integrated summary of efficacy (ISE) appears reasonable.