Hugel said that the U.S. Food and Drug Administration has accepted its biologics license application (BLA) for approving Letybo, a botulinum toxin (BTX) product.

Before the FDA's acceptance, Hugel had started phase 3 clinical trials for its BTX product to advance into the U.S. market in 2015 and submitted the BLA for its BTX product, Letybo (50 and 100 units), for treating forehead wrinkles to the FDA on March 31.

According to the notification sent by the FDA, the deadline for review of product approval is March 31, 2022, based on the U.S. Prescription Drug User Fee Act (PDUFA).

"Although the overall size of the U.S. toxin market is larger than that of the Korean market, the experience rate with botulinum toxin products is low," a company official said. "Therefore, Hugel's entry into the U.S. toxin market will contribute to expanding the market."

Through strategic sales and marketing, the company plans to become one of the top three local brands within three years of entering the market by expanding demand in the local market, the official added.

Hugel America President James Hartman also said, "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 U.S. by delivering high-quality beauty solutions accessible and attainable."

The company expects that Hugel America will emerge as a key player in the growing medical aesthetics market, he added.

According to the company, the U.S. BTX market is estimated at around 2 trillion won ($1.7 billion), with the market expected to continue to grow 10 percent annually until 2029.

The U.S. is an essential forward base for local companies to expand the influence of their products in the global market.

In October 2018, Hugel established Hugel America, a local subsidiary in the U.S., along with Croma, an Austrian pharmaceutical company specializing in medical aesthetics.