Vanda Seeks FDA Commissioner Review of Outgoing CDER Director's Decision to Uphold Approval of Two Generic Versions of Hetlioz庐
Vanda Pharmaceuticals (Nasdaq: VNDA) has requested FDA Commissioner Martin Makary to review a recent decision regarding generic versions of Hetlioz庐. 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庐. Vanda argues this reflects an institutional bias toward approving generic drugs regardless of evidence standards.
Vanda Pharmaceuticals (Nasdaq: VNDA) ha chiesto al commissario della FDA Martin Makary di riesaminare una recente decisione relativa alle versioni generiche di Hetlioz庐. La petizione di revisione fa seguito alla decisione dell'uscente direttrice del CDER Jacqueline Corrigan-Curay di confermare l'approvazione di due versioni generiche del farmaco, nonostante le citizen petition presentate da Vanda nel 2023 che contestavano tali approvazioni.
La controversia riguarda gli studi di bioequivalenza che Vanda ritiene essere viziati: in particolare, sottolinea che gli studi sono stati condotti esclusivamente su soggetti maschi indiani e hanno mostrato incongruenze nei dati, inclusi livelli di esposizione superiori a pi霉 del doppio rispetto a quelli di Hetlioz庐. Vanda sostiene che ci貌 rifletta un pregiudizio istituzionale volto ad approvare i farmaci generici indipendentemente dagli standard probatori.
Vanda Pharmaceuticals (Nasdaq: VNDA) ha solicitado al comisionado de la FDA, Martin Makary, que revise una decisi贸n reciente sobre las versiones gen茅ricas de Hetlioz庐. La petici贸n de revisi贸n sigue a la decisi贸n de la directora saliente del CDER, Jacqueline Corrigan-Curay, de mantener la aprobaci贸n de dos versiones gen茅ricas del medicamento, pese a las peticiones ciudadanas que Vanda present贸 en 2023 impugnando esas aprobaciones.
La controversia se centra en los estudios de bioequivalencia que, seg煤n Vanda, son defectuosos: en concreto, se帽ala que los estudios se realizaron 煤nicamente en sujetos varones indios y mostraron inconsistencias preocupantes en los datos, incluidos niveles de exposici贸n superiores a m谩s del doble que los de Hetlioz庐. Vanda sostiene que esto refleja un sesgo institucional hacia la aprobaci贸n de gen茅ricos sin atender a los est谩ndares de la evidencia.
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雲茧瀫鞚� Vanda臧� 瓴绊暔鞚� 鞛堧嫟瓿� 氤措姅 靸濍頃欖爜霃欕摫靹�(氚旍澊鞓れ澊韤措矊霟办姢) 鞐瓣惮鞐� 歆戩霅橃柎 鞛堨姷雼堧嫟. Vanda電� 頃措嫻 鞐瓣惮霌れ澊 鞚鸽弰 雮劚 雽�靸侅瀽鞐愱矊靹滊 靾橅枆霅橃棃瓿�, 項ろ媭毽槫歃堨棎 牍勴暣 雲胳稖 靾橃鞚� 霊� 氚� 鞚挫儊鞚� 霌� 雿办澊韯� 攵堨澕旃橁皜 甏�彀半悩鞐堧嫟瓿� 歆�鞝來暕雼堧嫟. Vanda電� 鞚措煬頃� 鞝愳澊 歃濌卑 旮办瓿� 氍搓磤頃橁矊 鞝滊劋毽� 鞎诫 鞀轨澑鞚� 鞖办劆頃橂姅 鞝滊弰鞝� 韼疙枼鞚� 氚橃榿頃滊嫟瓿� 欤检灔頃╇媹雼�.
Vanda Pharmaceuticals (Nasdaq: VNDA) a demand茅 au commissaire de la FDA, Martin Makary, de r茅examiner une d茅cision r茅cente concernant les versions g茅n茅riques d'Hetlioz庐. Cette requ锚te de r茅vision fait suite 脿 la d茅cision de la directrice sortante du CDER, Jacqueline Corrigan-Curay, de maintenir l'approbation de deux versions g茅n茅riques du m茅dicament, malgr茅 les p茅titions citoyennes d茅pos茅es par Vanda en 2023 contestant ces approbations.
La controverse porte sur des 茅tudes de bio茅quivalence que Vanda juge d茅faillantes : elle souligne en particulier que les 茅tudes ont 茅t茅 men茅es uniquement sur des sujets masculins indiens et ont montr茅 des incoh茅rences de donn茅es pr茅occupantes, notamment des niveaux d'exposition sup茅rieurs 脿 plus du double de ceux d'Hetlioz庐. Vanda soutient que cela refl猫te un biais institutionnel en faveur de l'approbation des g茅n茅riques, quel que soit le niveau des preuves.
Vanda Pharmaceuticals (Nasdaq: VNDA) hat den FDA-Kommissar Martin Makary gebeten, eine k眉rzliche Entscheidung zu den Generika von Hetlioz庐 zu 眉berpr眉fen. Die 脺berpr眉fungsbitte folgt auf die Entscheidung der scheidenden CDER-Direktorin Jacqueline Corrigan-Curay, die Zulassung von zwei Generikaversionen des Medikaments trotz der von Vanda im Jahr 2023 eingereichten B眉rgerpetitionen, die diese Zulassungen anfochten, aufrechtzuerhalten.
Der Streit dreht sich um die 叠颈辞盲辩耻颈惫补濒别苍锄蝉迟耻诲颈别苍, die Vanda als fehlerhaft bezeichnet: Insbesondere weist das Unternehmen darauf hin, dass die Studien ausschlie脽lich an indischen m盲nnlichen Probanden durchgef眉hrt wurden und besorgniserregende Dateninkonsistenzen zeigten, unter anderem eine Exposition, die mehr als das Doppelte der von Hetlioz庐 betrug. Vanda argumentiert, dies widerspiegle eine institutionelle Voreingenommenheit zugunsten der Zulassung von Generika unabh盲ngig von den Beweisstandards.
- None.
- 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庐
- FDA bureaucracy suggests a two-month delay just to decide whether to review the decision
- Potential regulatory issues could affect Hetlioz庐 market position
Insights
Vanda's challenge to FDA's generic approvals threatens revenue, but faces uncertain regulatory outcome with lengthy timeline ahead.
Vanda Pharmaceuticals is fighting to protect its Hetlioz庐 franchise by challenging the FDA's approval of two generic competitors. This represents a critical regulatory battle with significant revenue implications for the company. Hetlioz庐 (tasimelteon) is approved for Non-24-Hour Sleep-Wake Disorder and is likely a substantial revenue driver for Vanda.
The company's petition to the new FDA Commissioner Martin Makary centers on two key scientific arguments: first, that bioequivalence studies conducted only in Indian males are insufficient for establishing equivalence across the broader U.S. population; and second, that at least one generic showed blood exposure levels more than double that of branded Hetlioz庐, raising serious safety concerns.
The regulatory timeline appears protracted, with FDA officials indicating a two-month decision period just to determine if the Commissioner will review the case. This suggests any resolution is still quarters away, during which time generic competition could erode Vanda's market share.
The tone of Vanda's press release is notably confrontational, referencing "FDA's unacceptable culture of bias" and demanding "the rule of law return to the FDA." This aggressive approach signals the company views this as an existential threat to a key product line. The reference to Katherine Eban's expos茅 on generic drug approval problems suggests Vanda is attempting to position its challenge within a broader narrative of systemic FDA failures.
For investors, this represents significant uncertainty around future Hetlioz庐 revenues, with the outcome highly dependent on regulatory decisions rather than market factors.
In 2023, Vanda filed citizen petitions challenging the FDA's approval of two generic versions of Vanda's drug Hetlioz庐. 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庐.
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 聽and follow us on X @vandapharma.
About HETLIOZ庐
For full
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS聽
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庐, 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.
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