Search Results for keywords:"Vanda Pharmaceuticals"

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Search Results: keywords:"Vanda Pharmaceuticals"

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  • 2025-01027 — Proposal to Refuse to Approve a New Drug Application for TRADIPITANT; Opportunity for a Hearing
    Type:Notice
    Citation:90 FR 4748
    Reading Time:about 13 minutes

    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.

    Simple Explanation

    The FDA is saying "no" to a new medicine from a company called Vanda because they need more proof that it's safe and works well. They are giving the company a chance to argue why it should be approved.

  • 2025-03697 — Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)
    Type:Notice
    Citation:90 FR 11542
    Reading Time:about 2 minutes

    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.