Hugel America Announces FDA Acceptance of BLA for LetibotulinumtoxinA to Treat Glabellar Lines

Posted By American Med Spa Association, Thursday, October 28, 2021

Hugel America, Inc., a growth focused joint venture between aesthetic market-leading partners Hugel Inc., and Croma-Pharma GmbH, today announced that the Biologics License Application (BLA) forLetibotulinumtoxinA for Injection, to treat moderate to severe glabellar (frown) lines in adult patients has been accepted for review by the U.S. Food and Drug Administration (FDA).
In its correspondence, the FDA set a Prescription Drug User Fee Act (PDUFA) action date of March 31, 2022. Hugel initiated the pivotal clinical study program in support of LetibotulinumtoxinA in 2015 and submitted the BLA on March 31, 2021.

"The FDA's acceptance of our BLA is an important milestone for Hugel as it brings us one step closer to our goal of becoming a top aesthetics brand in the US by delivering high quality beauty solutions that are accessible and attainable," said James Hartman, President, Hugel America. "The groundwork has been done in the botulinum toxin category, but there's still plenty of opportunity for growth. We believe the market can continue to evolve and we look forward to participating in that evolution."  

LetibotulinumtoxinA is available in 28 countries worldwide and has been the market leader for five consecutive years in South Korea, one of the world's most dynamic markets.

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