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PDUFA Date Set for Botulax


Hugel America announces the BLA application FDA approval for letibotulinumtoxinA as a treatment for glabellar lines in adult patients.

The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of March 31, 2022, for LetibotulinumtoxinA (Botulax; Hugel America, Inc), a joint venture between Hugel America, Inc. and Croma-Pharma GmbH, as a neurotoxin to treat moderate to severe glabellar (frown) lines in adult patients.1 The Biologics License Application (BLA) was accepted for review on June 15, 2021. 

Hugel initiated a 2015 study program (NCT01791920) support of LetibotulinumtoxinA 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 of 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."

Currently, letibotulinumtoxinA is available in 28 countries and has been a leader in the South Korean market for 5 years straight, according to the release. 

Hugel America is also trying to expand into Canada, Australia, and New Zealand.


1. Inc HA. Hugel America, Inc. announces U.S. FDA acceptance of biologics license application (BLA) for letibotulinumtoxinA for injection to treat glabellar (frown) lines. Cision PR Newswire. Press Release. June 15, 2021. Accessed June 17, 2021. https://www.prnewswire.com/news-releases/hugel-america-inc-announces-us-fda-acceptance-of-biologics-license-application-bla-for-letibotulinumtoxina-for-injection-to-treat-glabellar-frown-lines-301312900.html 

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