Vanda Pharmaceuticals Challenges FDA's Generic Drug Approvals for Hetlioz®
- Vanda Pharmaceuticals is challenging FDA approvals for two generic versions of its drug Hetlioz®, citing inadequate studies.
- The company argues the FDA's decisions may compromise public health safety due to insufficient evidence and small trial samples.
- Vanda advocates for stricter regulatory practices to ensure the integrity of the drug approval process for patient safety.
Vanda Pharmaceuticals Challenges Generic Approvals at FDA
Vanda Pharmaceuticals Inc. is currently in a critical dialogue with the U.S. Food and Drug Administration (FDA) regarding the approval of two generic versions of its flagship drug, Hetlioz®. On August 21, 2025, the company formally requested that Martin Makary, the FDA Commissioner, review the decision made by Jacqueline Corrigan-Curay, the outgoing director of the FDA's Center for Drug Evaluation and Research (CDER). Vanda has persistently contested these approvals since 2023, citing citizen petitions that allege the decision-making process was compromised by inadequate studies. The company expresses particular concern over the small sample size of the trials, which predominantly involved Indian male subjects, arguing that these studies do not accurately reflect the diverse population in the United States.
Vanda's challenges are rooted in the idea that the FDA's recent decisions may not meet the rigorous legal and scientific standards necessary for public health safety. The company highlights significant discrepancies in the data regarding drug exposure levels, which the FDA deemed acceptable based on claims of differing psychological states among trial participants. Vanda contends that such an approach undermines the integrity of the drug approval process and reflects a troubling trend within the FDA toward hastily approving generic drugs without sufficient evidence. The company is calling for a return to stringent regulatory practices under Dr. Makary's leadership, emphasizing that adherence to established guidelines is crucial for ensuring the safety and efficacy of medications available to the public.
As the FDA's Office of the Commissioner deliberates on whether to review Vanda's request, the pharmaceutical company remains committed to advocating for lawful practices in drug approvals. Vanda emphasizes that the integrity of the drug approval process is essential not only for the company but also for patients who rely on effective treatments for their health conditions. The outcome of this review could have significant implications not only for Vanda's business but also for the industry standard regarding the approval of generic medications.
In the broader context, Vanda Pharmaceuticals continues to focus on developing innovative therapies aimed at addressing significant unmet medical needs. The company's commitment to improving patient lives remains unwavering, as it navigates these regulatory challenges. More information about Vanda’s initiatives and products can be found on their official website, www.vandapharma.com.