Hugel said Wednesday that it had completed the U.S. Food and Drug Administration's mid-cycle meeting, an intermediate inspection process for the product approval review of its botulinum toxin (BTX) product, Letybo,

"Before the meeting, the FDA conducted a current good manufacturing practice (cGMP) inspection for nine days from Aug. 12-20, and verified the manufacturing facilities and quality management system of Hugel second plant in charge of the production of Letybo," the company said. "After completing the inspection, Hugel submitted additional documents to respond to some of the supplements requested by the FDA within the last 10 days, and we expect to get an approval without any difficulty."

Hugel submitted an application for product approval for Letybo 50 units and 100 units in March.

In June, the company received an acceptable for review letter from the FDA. According to the official document, based on the U.S. Prescription Drug User Fee Act (PDUFA), the FDA will complete the review for approval of Letybo by March 31 of next year.

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.

"We aim to rise to one of the top three local brands within three years by entering the local market more aggressively and strategically through our subsidiary," a company official said. "As we expect that the FDA's inspection will end smoothly, we plan to accelerate the entry into the U.S. market."

Based on Hugel's excellent manufacturing facilities and systems certified through FDA's due diligence, the company will continue to strive to produce high-quality products recognized in the global market, she added.