The Food and Drug Administration (FDA) has announced a decision to deny Vanda Pharmaceuticals a hearing regarding their supplemental new drug application for HETLIOZ, which is intended to treat insomnia by aiding in sleep initiation. The FDA concluded that the application did not provide sufficient evidence to prove the drug's effectiveness and safety for this new use. Previously, on March 4, 2024, the Center for Drug Evaluation and Research (CDER) issued a complete response letter indicating Vanda's application could not be approved as is. After reviewing submissions from both parties, the FDA finalized their decision not to approve the new indication for the drug on February 28, 2025.
Simple Explanation
The FDA has said "no" to Vanda Pharmaceuticals, who wanted to change their drug HETLIOZ to help people fall asleep, because they didn't show enough proof that it works safely for this new purpose.