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# Hugel Refiles BLA Addressing FDA Concerns
- URL: https://www.fdaweb.com/hugel-refiles-bla-addressing-fda-concerns/
- Published: 2023-09-01T12:00:00.000Z
- Updated: 2026-09-14T18:54:05.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155238

Korea-based Hugel has resubmitted its BLA for its botulinum toxin Letybo (letibotulinumtoxinA), indicated for treating glabellar (frown) lines. The company received a complete response letter in April, and it says the resubmission addresses “facility management and supplementary work” that the agency's letter requested. Hugel expects a review decision in six months, and if favorable the product would launch in the first quarter of 2024.