Unicycive resubmits NDA for oxylanthanum carbonate after June 2026 CRL
The company said the new submission adds manufacturing data from a second vendor and expects FDA acceptance within 30 days.
SEC filing
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Unicycive says FDA has assigned facility inspection for OLC manufacturing vendor
The company expects to resubmit its NDA for oxylanthanum carbonate once the third-party manufacturing inspection is completed successfully.
SEC filing