Complete Response Letters

Xeris Pharmaceuticals, Inc.: Gvoke

What FDA's Complete Response Letters to the company say, in the letters' own words.

EphemerisX Research · Sep 30, 2026 · Sources: FDA, SEC

Complete Response Letter, Feb 9, 2024

You may establish an adequate scientific bridge by conducting a new a pharmacokinetics (PK) study in humans that demonstrates comparable bioavailability of your proposed product and the relied-upon listed drug for IV administration.

Complete Response Letter · Feb 9, 2024Open the letter ↗CRL_NDA212097_20240209:p1:s28

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Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.