ADHD Drug CTx-1301 Receives Complete Response Letter - Summary - MDSpire
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ADHD Drug CTx-1301 Receives Complete Response Letter

Company says the agency requested additional Chemistry, Manufacturing and Controls information.

  • By

  • Kathryn Wighton

  • June 2, 2026

  • 2 min

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Objective:

To report on the FDA's Complete Response Letter regarding CTx-1301 for ADHD.

Key Findings:
  • The FDA's feedback was limited to specific CMC information requests.
  • CTx-1301 is designed as a once-daily, multi-core tablet for ADHD.
  • The product is under evaluation via the FDA’s 505(b)(2) pathway.
Interpretation:

N/A

Limitations:
  • The FDA letter was not released to the public.
  • CTx-1301 remains investigational and is not approved for ADHD.
Conclusion:

N/A

Original Source(s)

ADHD Drug CTx-1301 Receives Complete Response Letter

  • by Kathryn Wighton

  • June 2, 2026

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