Huons wins FDA approval for 2 injectable lidocaine products

Huons, a Korean pharmaceutical company, said Wednesday that it has received U.S. FDA approval for two new injectable lidocaine products, targeting the North American anesthetics market.

According to the company, the FDA granted abbreviated new drug application (ANDA) approvals for 1% (200 mg/20 mL) and 2% (400 mg/20 mL) multiple-dose vials for lidocaine hydrochloride injection.

The newly approved multi-dose vial products are preservative-containing formulations that can be used repeatedly after opening, offering more versatility compared to single-dose options. Huons noted that these products demonstrated pharmaceutical equivalence to the reference listed drug, Xylocaine Injection, as was the case with its previously approved single-dose 1 percent and 2 percent lidocaine hydrochloride injections in 5 mL vials.

These latest approvals mark Huons’ sixth and seventh FDA-cleared products. The company has progressively expanded its U.S. portfolio since 2017, starting with a saline injection, followed by multiple lidocaine and bupivacaine injectable products.

Three of these products, including the 0.75 percent bupivacaine hydrochloride injection, have also secured Health Canada approval and are currently exported to the Canadian market.

Huons said it plans to leverage the new approvals to further increase its exports to North America, where the local anesthetics market is estimated to be worth around 500 billion won ($357.2 million).

The company also intends to scale up production, with its newly built injectable production line at its Jecheon Plant 2 scheduled to begin full operation later this year.

“This FDA approval is significant as the two lidocaine products are high-utility, multi-dose vials that meet diverse clinical needs,” Huons CEO Song Soo-young said. “We will continue to strengthen our presence in the North American market with a broad range of high-quality local anesthetics.”