Complete response letterLetter dated August 7, 2026
Complete response letter to ITM Solucin GmbH
NDA 218705
FDA issued a complete response letter to ITM Solucin GmbH for NDA 218705, dated August 7, 2026.
On the record
- Applicant
- ITM Solucin GmbH
- Application
- NDA 218705
- Letter dated
- 2026-08-07
- FDA center
- Center for Drug Evaluation and Research
The full record
An account shows the text of the letter: the deficiencies FDA listed.
What a complete response letter is
A complete response letter tells an applicant that FDA has finished reviewing a drug or biologic application and will not approve it in its present form. The letter describes the deficiencies FDA found. FDA began publishing these letters in July 2025.
More
Watch ITM Solucin GmbH
A free account shows the last 7 days of every FDA, SEC and ClinicalTrials.gov source. Pro adds a watchlist: one email when FDA acts on a company you name.
From openFDA complete response letters. The record may have changed since it was read.
Approve Suite is not affiliated with FDA, or with ITM Solucin GmbH. Informational only.
See something wrong on this page? Write to info@approvesuite.com and we will check it against the source. How corrections work.