US FDA OKs Huons’ 2% lidocaine for local anesthesia

Huons said it has received marketing approval from the U.S. Food and Drug Administration (FDA) for a 2% lidocaine Inj. 5 mL Vial for local anesthesia. 

The approval comes after the company submitted the Abbreviated New Drug Application (ANDA) in December 2022. 

The FDA granted the approval because the company demonstrated bioequivalence of its product compared to the competitor, Fresenius Kabi USA's Xylocaine Injection.

"This is the fifth FDA approval for Huons' injectable products, demonstrating the quality and safety of our injectables in the global market and solidifying the company's position as a global healthcare company," the company said.

Previously, Huons had received approvals for four products -- sodium chloride Inj. (July 2017), 1% Lidocaine Hydrochloride Inj. 5mL (April 2018), 0.75% Bupivacaine Hydrochloride Inj. 2mL (December 2019), and 1% Lidocaine Hydrochloride Injection 5mL Vial (May 2020).

"With these approvals, Huons plans to promote the high quality of Korean local anesthetics and contribute to the stable supply of lidocaine, which is facing a chronic shortage in North America," the company said. "We will also focus on expanding exports to the North American market as the exports of four previously approved products in 2022 soared to 12.3 billion won ($9.5 million), a 69 percent increase compared to 2021."

Huons Co-CEO Song Soo-young also said, "We are pleased once again to demonstrate the superior quality of Huon's injectable products and look forward to further strengthening our position in the North American market."

Meanwhile, Huons is expanding its production line to handle the growing volume of overseas injectable exports.

The company said it would invest 24.5 billion won to expand its vial and cartridge injectable production lines at its Jecheon Plant 2.

Upon completion of the expansion, the new vial line will have the capacity to produce 79 million vials, about three times the capacity of the existing line, and the new cartridge line will have the capacity to produce 210 million cartridges, about 1.5 times increase from the current production capacity.

The company stressed that the expansion will be fully operational in the second half of 2025.