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Home > Primary Care Today > “Tentative Approval”: Understanding the FDA Ruling on Once-Nightly Sodium Oxybate
Podcast: Primary Care Today
Episode:

“Tentative Approval”: Understanding the FDA Ruling on Once-Nightly Sodium Oxybate
Category: Science & Medicine
Duration: 00:00:00
Publish Date: 2022-12-30 05:00:00
Description: Host: Sara W. Koblitz
Guest: Michael J. Thorpy, MD

While most clinicians are aware of a drug being either “approved” or “not approved” by the FDA, many are not familiar with the term “tentative approval.” Leading experts, attorney Sara Koblitz, JD, and Dr. Michael Thorpy, review the FDA approval process, explore how “tentative approval” is currently impacting treatment in the field of sleep medicine, and discuss how “non-drug” 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’re truly on the cusp of a new awakening in sleep medicine.
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