Committee split over KPV after FDA warns of inconsistent naming and missing quality data
FDA reviewers told the committee KPV nominations lacked clear identification and COA detail (impurities/aggregation/BET), and that human evidence was limited; the advisory panel split on votes, with some members willing to allow restricted topical access and others voting against listing until characterization and safety data improve.
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FDA staff presented the committee with a technical finding: nominations for KPV used a common name and in some submissions COAs referenced different chemical forms, making it unclear whether the nominated bulk drug substance was the free base or an acetate salt. "Because the information provided in the nomination package was inconsistent, it's unclear which KPV‑related BDS was intended for nomination," said chemistry reviewer Jing Li.
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