UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 7, 2024 (
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| Item 8.01. | Other Events. |
On March 6, 2024, Vanda Pharmaceuticals Inc. (“Vanda”) issued a press release announcing that it had received a Complete Response Letter from the U.S. Food and Drug Administration regarding Vanda’s supplemental New Drug Application for HETLIOZ® in the treatment of insomnia.
The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits |
| Exhibit No. |
Description | |
| 99.1 | Press release of Vanda Pharmaceuticals Inc. dated March 6, 2024. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
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.
| Dated: March 7, 2024 | VANDA PHARMACEUTICALS INC. | |||||
| By: | /s/ Timothy Williams | |||||
| Name: | Timothy Williams | |||||
| Title: | Senior Vice President, General Counsel and Secretary | |||||
Exhibit 99.1
Vanda Pharmaceuticals Announces FDA Update for supplemental NDA for HETLIOZ® in the Treatment of Insomnia
WASHINGTON, March 6, 2024 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that on March 4, 2024, it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) as part of its ongoing review of Vanda’s supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) in the treatment of insomnia characterized by difficulties with sleep initiation.
In July 2023, the FDA had assigned a Prescription Drug User Fee Act target date of March 4, 2024 for the completion of its review of the sNDA. As previously reported, on February 4, 2024, the FDA provided a notification stating that it identified deficiencies that precluded discussion of labeling and postmarketing requirements/commitments. Consistent with that notification, the FDA has issued a CRL, indicating that the FDA cannot approve the sNDA in its present form.
Vanda is reviewing the CRL and evaluating its next steps.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on X @vandapharma.
About HETLIOZ®
For full U.S. Prescribing Information for HETLIOZ®, including indication and Important Safety Information, visit www.hetlioz.com.
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com