regulatory
confidence high
sentiment positive
materiality 0.50
Cumberland Pharmaceuticals receives FDA waiver, $1.2M refund for RediTrex fees
CUMBERLAND PHARMACEUTICALS INC
- FDA granted barrier-to-innovation waiver based on ifetroban clinical programs addressing unmet medical needs.
- Company will receive refund of approximately $1.2 million in prescription drug program fees for RediTrex.
- Refund expected within 45 days from FDA's Office of Financial Management.
- Waiver follows Cumberland's April 3, 2023 request for reconsideration through counsel.