Tentative Approval: Understanding the FDA Ruling on Once-Nightly Sodium Oxybate
Host: Sara W. Koblitz
\n\n Guest: Michael J. Thorpy, MD
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Since the release of this activity, the FDA has approved the use of Once-Nightly Sodium Oxybate. Visit the FDA statement dated May 1, 2023.
https://firstwordpharma.com/story/5734060
While most clinicians are aware of a drug being either \u201capproved\u201d or \u201cnot approved\u201d by the FDA, many are not familiar with the term \u201ctentative approval.\u201d Leading experts, attorney Sara Koblitz, JD, and Dr. Michael Thorpy, review the FDA approval process, explore how \u201ctentative approval\u201d is currently impacting treatment in the field of sleep medicine, and discuss how \u201cnon-drug\u201d issues are related to delayed FDA approval. Review the latest safety and efficacy pivotal trial data associated with once-nightly sodium oxybate and find out if we\u2019re truly on the cusp of a new awakening in sleep medicine.