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They were removed because the original nominators withdrew their nominations, which allowed the FDA to refer them to the Pharmacy Compounding Advisory Committee (PCAC) for formal review

The FDAs Pharmacy Compounding Advisory Committee will review whether to officially clear any of them for compounding at its July 23-24, 2026 meeting

It inhibits the activation of the transcription factor NF-B, reducing the production of pro-inflammatory cytokines (IL-1, TNF-, IL-6) and inflammatory mediators (PGE2, NO)

Second, while we concurred that avoiding post-cystoscopy infections is important, we noted that none of the studies the applicant submitted as evidence evaluated or assessed the VersaVue [TM] Single-Use Flexible Cystoscope and that none of the studies compared clinical outcomes, such as adverse events (including post-cystoscopy infection) associated with the use of the VersaVue [TM] Single-Use Flexible Cystoscope to clinical outcomes associated with reusable cystoscopes