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Complete Response Letters

Genentech, Incorporated: XOFLUZA

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, Nov 23, 2020

Cosmetic Act for XOFLUZA (baloxavir marboxil) for oral suspension.
Complete Response Letter · Nov 23, 2020 · p. 2Open the letter at p. 2 ↗CRL_NDA214410_20201123:p1:s13
Federal Food, Drug, and Cosmetic Act for XOFLUZA (baloxavir marboxil) 20 mg and 40 mg tablets.
Complete Response Letter · Nov 23, 2020 · p. 2Open the letter at p. 2 ↗CRL_NDA214410_20201123:p1:s16

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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.