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Comment: With respect to the newness criterion at 419.66(b)(1), the applicant reiterated that the VersaVue TM Single-Use Flexible Cystoscope received 510(k) clearance from FDA on October 6, 2023, and that it submitted an application for pass-through status on February 11, 2025, which is within 3 years of the initial market authorization

What they found: NR is rapidly absorbed orally , peak at 30 minutes NR is converted to NAD+ in multiple tissues , liver, muscle, blood Plasma NAD+ rises 2 to 8 after a single dose Optimal dosing regimens: 100 to 1000 mg No accumulation of toxic metabolites Why it matters: This is the reference pharmacokinetic publication for NR and NMN

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