The company argues that regulators relied on narrow study populations and overlooked major data inconsistencies, raising concerns about patient safety.
Retail chatter picked up around Vanda Pharmaceuticals on Thursday after the company formally asked U.S. Food and Drug Administration (FDA) Commissioner Martin Makary to review a decision upholding the approval of two generic versions of its sleep drug Hetlioz, intensifying its fight with regulators just days after winning a separate court battle.
In a filing, Vanda said it wants Makary to examine the ruling issued in July by Jacqueline Corrigan-Curay, the outgoing director of the FDA’s Center for Drug Evaluation and Research (CDER).
Her decision, made shortly before her retirement, sided with the Office of Generic Drugs in clearing two competing versions of Hetlioz despite what Vanda argues were “significant flaws” in the underlying studies.
The company said regulators accepted bioequivalence studies conducted only in Indian male subjects and overlooked data inconsistencies, including one generic that showed blood exposure levels more than twice those seen with Hetlioz.
Vanda also criticized what it described as an entrenched FDA bias toward approving generics “regardless of whether they meet the requisite legal and evidentiary standards.”
The latest push comes just days after Vanda scored a legal win in Washington, where a federal appeals court threw out the FDA’s rejection of Hetlioz as a jet lag treatment.
The judges faulted the agency for giving the application only a cursory review and sent it back, saying the FDA must now either approve the drug for that use or give Vanda a proper hearing.
The ruling revived a regulatory dispute dating back to 2018, when Vanda first sought approval for the indication.
Hetlioz is already cleared in the U.S. to treat Non-24-Hour Sleep-Wake Disorder and sleep problems linked to Smith-Magenis Syndrome. It remains one of Vanda’s key products, generating $16.2 million in the second quarter of 2025, about 31% of the company’s revenue.
Vanda said bureaucrats have indicated it may take up to two months for the FDA’s Office of the Commissioner to decide whether Makary himself will review the generics decision.
“It is time that the rule of law return to the FDA under Dr. Makary’s leadership,” the company said in its statement.
On Stocktwits, retail sentiment for Vanda was ‘bullish’ amid ‘high’ message volume.
Vanda’s stock has declined nearly 6% so far in 2025.
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