FDA grants barrier-to-innovation waiver; Cumberland to receive ~$1.9M refund for RediTrex fees

CUMBERLAND PHARMACEUTICALS INC

FDA reversed prior denial and granted barrier-to-innovation waiver on March 30, 2023, after reconsideration request.
Refund of approximately $1.9 million in prescription drug program fees for RediTrex expected within 45 days.
Waiver tied to Cumberland's ifetroban clinical programs addressing unmet medical needs.
Original $1.9M fee paid Oct 4, 2021; initial denial Nov 1, 2021; reconsideration filed Nov 28, 2021.

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