Hugel said it has resubmitted its new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for 50 and 100 units of Letybo (brand name in Korea: Botulax), its botulinum toxin (BTX) preparation.

The NDA is the third challenge after the company received supplemental requests for the last two license applications on two separate occasions.

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.

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

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

Accordingly, the company completed the supplemental work on the plant equipment and resubmitted the license application for the third time. 

The company expects to obtain the license in the first quarter of next year, as it takes about six months to obtain the license after submitting the FDA documents.

"The U.S. is the world's largest BTX market and is considered one of the top three global markets, along with China and Europe, where we are already marketing Letybo," a Hugel spokesperson said. "We will do our best to make Hugel become a leading company in the global BTX industry through successful entry into the U.S. market."