Vanda Seeks FDA Commissioner Review of Outgoing CDER Director's Decision to Uphold Approval of Two Generic Versions of Hetlioz®
Rhea-AI Summary
Vanda Pharmaceuticals (Nasdaq: VNDA) has requested FDA Commissioner Martin Makary to review a recent decision regarding generic versions of Hetlioz®. The review petition follows outgoing CDER Director Jacqueline Corrigan-Curay's decision to uphold the approval of two generic versions of the drug, despite Vanda's 2023 citizen petitions challenging these approvals.
The controversy centers on bioequivalence studies that Vanda claims are flawed, specifically noting that the studies were conducted only on Indian male subjects and showed concerning data inconsistencies, including exposure levels more than double those of Hetlioz®. Vanda argues this reflects an institutional bias toward approving generic drugs regardless of evidence standards.
Positive
- None.
Negative
- FDA approved generic versions despite studies only conducted on Indian male subjects, raising safety concerns
- One generic version showed concerning blood exposure levels more than double that of Hetlioz®
- FDA bureaucracy suggests a two-month delay just to decide whether to review the decision
- Potential regulatory issues could affect Hetlioz® market position
News Market Reaction – VNDA
In the Aug 22 session, VNDA gained 5.32%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
AI-generated analysis. How Rhea-AI works. Not financial advice.
In 2023, Vanda filed citizen petitions challenging the FDA's approval of two generic versions of Vanda's drug Hetlioz®. Vanda argued that each was improperly approved in light of significant flaws in the studies and data presented.
In July 2025, outgoing CDER director Corrigan-Curay issued a decision siding with the prior FDA decision to approve these generic versions, seemingly agreeing that generic drug manufacturers need only conduct small studies that include only Indian male subjects to establish bioequivalence for use in the general US population. Further, in the case of one generic version, Corrigan-Curay accepted that significant inexplicable data inconsistencies measuring a drug's exposure levels in the blood could be justified by the supposedly different "psychological state" of participants at different times and that it was of no concern that one of the generic versions showed exposure levels more than double those Vanda has obtained for Hetlioz®.
This decision reflects the FDA's unacceptable culture of bias toward approving generic drugs regardless of whether they meet the requisite legal and evidentiary standards, endangering the well-being of American citizens. Katherine Eban extensively exposed this serious flaw in her 2019 book Bottle of Lies: The Inside Story of the Generic Drug Boom, but it appears to remain entrenched at the FDA.
Vanda is now asking Commissioner Makary to review this decision. Unfortunately, FDA bureaucrats have suggested that the Office of the Commissioner (not the Commissioner) will take two months to decide whether the Office of the Commissioner will review the merits of this decision. It is time that the rule of law return to the FDA under Dr. Makary's leadership. Agency personnel must abide by the law and Commissioner priorities.
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
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this press release, including, but not limited to statements regarding the expected timeframe for a decision by the Office of the Commissioner whether to review the decision of the outgoing director of CDER with respect to the FDA's prior approvals of two generic versions of Hetlioz®, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, the ability of the Officer of the Commissioner to reach a decision within the expected timeframe. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the
All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Corporate Contact:
Kevin Moran
Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/vanda-seeks-fda-commissioner-review-of-outgoing-cder-directors-decision-to-uphold-approval-of-two-generic-versions-of-hetlioz-302536237.html
SOURCE Vanda Pharmaceuticals Inc.