UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
June 7, 2023 (June 2, 2023 )
Date of Report (date of earliest event reported)
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) | |||||||||
(Address of Principal Executive Offices)
(615 ) 255-0068
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Securities registered pursuant to Section 12(b) of the Act:
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Emerging growth company ☐
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Item 8.01 Other Events
On June 2, 2023, the U.S. Food and Drug Administration (the “FDA” or the “agency”) informed Cumberland Pharmaceuticals Inc. (“Cumberland” or the “Company”) that it had granted a barrier-to-innovation waiver, which will result in a refund of approximately $1.2 million that the Company previously paid for prescription drug program fees associated with its RediTrex® product line.
The FDA granted the barrier-to-innovation waiver after concluding that the Company met the statutory criteria, based on the innovation associated with Cumberland’s ifetroban clinical development programs which are designed to address a series of unmet medical needs.
The FDA’s decision was in response to a request for reconsideration that Cumberland provided, through its attorney, on April 3, 2023. Cumberland paid the FDA the fiscal year 2023 RediTrex prescription drug program fees in the amount of approximately $1.2 million on or about December 28, 2022. The fees were assessed under the Prescription Drug User Fee Act.
The FDA informed Cumberland on June 2, 2023, that the agency’s Office of Financial Management had been asked to provide a refund of the fees, which is expected within 45 days.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Cumberland Pharmaceuticals Inc. | ||||||||||||||||||||
| Dated: June 7, 2023 | By: | /s/ John Hamm | ||||||||||||||||||
| John Hamm | ||||||||||||||||||||
| Chief Financial Officer | ||||||||||||||||||||