The FDA has issued a complete response letter for Galderma’s QM-1114 biologics license application for the treatment of moderate to severe frown lines and crow’s feet, according to a manufacturer-issued press release.
The letter cites deficiencies related to the chemistry, manufacturing and control processes of the drug, according to the release. Issues related to safety and efficacy were not a concern.
The biologics license application for QM-1114 (relabotulinumtoxinA), a novel botulinum toxin A liquid formulation, was submitted to treat adults with moderate to severe glabellar