Hugel America, Inc. Announces U.S. FDA Acceptance of Biologics License Application (BLA) for LetibotulinumtoxinA for Injection to Treat Glabellar (Frown) Lines

- Prescription Drug User Fee Act (PDUFA) target action date of March 31, 2022 -

NEWPORT BEACH, CA, USA I June 15, 2021 I 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) for LetibotulinumtoxinA 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.

Hugel America also plans to accelerate its global expansion into additional markets including Canada, Australia and New Zealand.

About Hugel America, Inc.
Hugel America, Inc. (Hugel Aesthetics) is a growth focused joint venture between aesthetic market-leading partners Hugel Inc., and Croma-Pharma GmbH to develop and commercialize botulinum toxin, hyaluronic acid fillers, and additional aesthetic portfolio products in the United States, Canada, Australia, and New Zealand. Hugel Aesthetics is dedicated to making a difference by transforming patient experiences. For more information, visit us at www.hugel.co.kr/en.

SOURCE: Hugel America

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