Huons Receives US FDA Approval for Local Anesthetic '2% Lidocaine'

5th FDA Approval Following 1% Lidocaine and Others

Huons announced on the 19th that it has obtained approval for the Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for its 2% Lidocaine Injection 5㎖ vial (2% Lidocaine 5㎖).

Huons CI. [Image provided by Huons]

Huons applied for approval of the 5㎖ vial of the local anesthetic lidocaine last December, and explained that it succeeded in obtaining approval after proving bioequivalence with the reference drug, Fresenius Kabi USA's 'Xylocaine Injection.'

This approval marks Huons' fifth FDA approval. The company stated that it is significant in that it has promoted the quality and stability of its injectable drugs in the global market and solidified its position as a global healthcare company.

Previously, Huons had obtained approvals for four products: normal saline injection (July 2017), 1% lidocaine hydrochloride injection 5㎖ ampoule (April 2018), 0.75% bupivacaine hydrochloride injection 2mL ampoule (December 2019), and 1% lidocaine hydrochloride injection 5㎖ vial (May 2020). The 1% lidocaine local anesthetic also received supply approval in Canada last February following the U.S.

Through this approval, Huons plans to contribute to the stable supply of lidocaine, which has been experiencing chronic shortages in the North American region. Additionally, the company intends to focus on expanding exports to the North American market. In fact, last year, exports of four products including the lidocaine local anesthetic approved by the U.S. FDA's ANDA recorded sales of approximately 12.3 billion KRW in the U.S., a 69% increase compared to the previous year.

To handle the increasing volume of injectable drug exports overseas, Huons is expanding its production lines. The company is investing 24.5 billion KRW in its Jecheon Plant 2 to expand vial and cartridge injectable drug production lines. Once the expansion is completed, the new vial line will have a production capacity of 79 million vials, about three times the existing line's capacity of approximately 26 million vials, and the new cartridge line will have a capacity of 210 million cartridges, about 1.5 times the current 132 million cartridges. Full-scale operation of the injectable drug lines is expected in the second half of 2025.

Song Soo-young, CEO of Huons, said, "The recent FDA approval of the 2% lidocaine injection is Huons' fifth FDA approval following normal saline injection, 1% lidocaine ampoule and vial, and 0.75% bupivacaine." He added, "We will continue to strengthen our position in the North American market."