> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Galderma Sent Complete Response Letter
- URL: https://www.fdaweb.com/galderma-sent-complete-response-letter/
- Published: 2023-10-03T12:00:00.000Z
- Updated: 2026-09-14T18:59:50.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5155477

FDA has issued Galderma a complete response letter on its BLA for relabotulinumtoxinA (QM-1114), indicated for treating moderate-to-severe glabellar lines (frown lines) associated with corrugator or procerus muscle activity in adult patients as well as moderate-to-severe lateral canthal lines (crow’s feet) associated with orbicularis oculi muscle activity in adult patients.

The agency letter cites “certain deficiencies isolated to items related to chemistry, manufacturing, and controls processes,” Galderma says. “All other aspects of the BLA, including safety and efficacy related parts, did not solicit deficiencies to be addressed.” The company says it has identified changes to the manufacturing process to address FDA’s concerns, and it will be seeking further guidance from agency reviewers to resolve the issues.