Search Results for keywords:"Vanda Pharmaceuticals"

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.

The Food and Drug Administration (FDA) is proposing to reject the new drug application from Vanda Pharmaceuticals for TRADIPITANT capsules, intended to treat nausea in gastroparesis. The application was found lacking as it did not provide substantial evidence of the drug’s effectiveness and safety based on submitted studies and data. Vanda has the option to request a hearing to contest this decision, though they must address all the identified deficiencies. If no hearing request is filed, or if it is not deemed substantial, the FDA will officially deny the application.