Hugel reapplies for BTX approval in US
, 2022-10-07 01:29:22,
Hugel said Friday that it reapplied to the U.S. Food and Drug Administration (FDA) for marketing approval for Letybo (brand name in Korea: Botulax), its botulinum toxin formulation, to treat forehead wrinkles.
Hugel had sought the U.S. permit for Letybo 50 units and 100 units in March 2021.
However, the company received a CRL (Complete Response Letter) from the FDA in March this year.
A CRL is an outcome of the FDA review on Biologics License Applications (BLA) or New Drug Applications (NDA). The FDA issues a CRL to require additional field inspection or supplementary data. If a company receives a CRL, it must apply for approval again.
Hugel has since completed the data supplementation in accordance with the CRL and resubmitted the application to the FDA.
Usually, it takes about six months to obtain a permit after submitting documents in the U.S. Hugel expects Letybo will enter the U.S. market in the first half of 2023.
If the company obtains approval, Hugel America, its U.S. subsidiary established in 2018, will be responsible for the product’s marketing, distribution, and sale.
“The U.S. is the world’s largest BTX market, and will become one of the key markets for Hugel,” Hugel CEO Sohn Ji-hoon said. “As we are in the final stage for advancing into the U.S. market, we will do our best to successfully launch Letyvo…
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