Issued to Heron Therapeutics, Inc.. Application reviewed but not approved; deficiencies must be corrected.
Issued
June 26, 2020Application
NDA 505b1 • 211988
Product
ZYNRELEF KIT
Company
Heron Therapeutics, Inc.
Review center
Other
Stage
Final Decision
Response due
January 1, 2023
Assyro regulatory brief
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FDA's complete response letter contains source-text evidence related to Labeling, packaging, and proprietary name, Nonclinical evidence, Safety and adverse events, Chemistry, manufacturing, and controls. Theme counts identify where the letter discusses a topic; they do not replace review of the exact redacted letter.
Review the exact redacted FDA letter and address each stated deficiency before resubmission.
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Application reviewed but not approved; deficiencies must be corrected. Requires resubmission addressing deficiencies. FDA issued this letter to Heron Therapeutics, Inc. on June 26, 2020.
NDA 211988 is the application under which FDA issued this complete response letter for ZYNRELEF KIT to Heron Therapeutics, Inc.. It was reviewed by FDA Other. The letter is dated June 26, 2020.
FDA will not approve the application in its present form. The sponsor can resubmit after addressing every deficiency listed in the letter — which starts a Class 1 (two-month) or Class 2 (six-month) resubmission review clock — withdraw the application, or request an opportunity for a hearing.