Complete Response Letters
Heron Therapeutics, Inc.: Zynrelef
What FDA's Complete Response Letters to the company say, in the letters' own words.
Complete Response Letter, Jun 26, 2020
No complete sentence from this letter is available from the knowledge graph yet.
Complete Response Letter, Apr 30, 2019
CDER Inactive Ingredient Database (IID) and are, therefore, considered novel.
CRL_NDA211988_20190430:p1:s37Your toxicological risk assessment for the excipient maleic acid, which exceeds the maximum potency listing in the CDER Inactive Ingredients Database (IID), does not address the potential impact of maleic acid on embryo-fetal development in a second species (typically rabbit).
CRL_NDA211988_20190430:p1:s45More Complete Response Letters
Updated Sep 30, 2026 · built from 283 companies in the EphemerisX knowledge graph. This page is regenerated as companies are added.