Hugel said it received approval from the U.S. FDA for its botulinum toxin product, Letybo, in 50-unit and 100-unit dosages.

This FDA approval marks a significant development for Hugel, following its third attempt to gain approval for Letybo.

The company's journey to this point involved addressing feedback received from the FDA in the form of Complete Response Letters (CRLs).

A CRL is an outcome of the FDA review on Biologics License Applications (BLA) or 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 first applied to the FDA for approval of Letybo in March 2021, but more than a year later, in March 2022, the company received a complete response letter (CRL) to supplement the data on equipment and authorizations that Hugel had added to the plant since the company submitted its BLA.

Hugel had completed the data supplementation in accordance with the CRL and resubmitted the BLA application to the FDA in October of 2022.

However, the company received another CRL related to the plant management issue.

After fulfilling the FDA's requests for supplementary data and undergoing further inspections, Hugel again resubmitted its application, leading to the approval this time around.

The approval of Letybo by the FDA allows Hugel to enter the U.S. market, which is recognized as the largest BTX market globally.

This achievement complements Hugel's presence in other key markets, including China and Europe, making it one of the few companies to have a presence in all three major BTX markets worldwide.

To date, Letybo has received regulatory approvals in 63 countries.

"As a global medical aesthetics leader, we are excited to bring Letybo to the U.S. market, one of the largest and fastest-growing markets in the world,” a Hugel official said.

Thanks to the approval news, Hugel shares rose on Monday.

As of 10:30 a.m., the company’s shares stood at 199,800 won ($150.19), up 8.65 percent from the previous trading day.