Two lidocaine local anesthetic products from Huons have received item approval from the U.S. Food and Drug Administration (FDA), paving the way for their launch in the North American market.
On the 5th (local time), Huons announced that it had obtained approvals for the Abbreviated New Drug Applications (ANDAs) for "1% Lidocaine Injection Multi-Dose Vial (1% Lidocaine 200 mg/20mL)" and "2% Lidocaine Injection Multi-Dose Vial (2% Lidocaine 400 mg/20mL)" from the U.S. FDA on the 7th. A vial is a product in the form of a storage container for holding injectable solutions.
The company noted that it applied for item approval in January and received the approval in four months. The multi-dose vial products now approved are a formulation that incorporates preservatives into the previously approved lidocaine injections, allowing for multi-use after opening. Similar to the existing approved products, which include 1% and 2% lidocaine hydrochloride injection single-dose vials of 5mL, they have demonstrated drug equivalence with the comparative drug, Xylocaine Injection.
As a result, the total number of Huons' products exported to the U.S. has increased to seven. Previously, the company obtained approvals for five products: saline injection (July 2017), 1% lidocaine hydrochloride injection 5mL ampoule (April 2018), 0.75% bupivacaine hydrochloride injection 2mL ampoule (December 2019), 1% lidocaine hydrochloride injection 5mL vial (May 2020), and 2% lidocaine hydrochloride injection 5mL vial (June 2023). Three of them, including the 0.75% bupivacaine hydrochloride injection, have already been approved by Health Canada and are being exported.
Huons plans to focus on expanding exports to the North American market. The North American local anesthetics market is said to be worth 500 billion won. In particular, the company plans to fully activate the new injection line at its second factory in Jecheon starting in the second half of this year to increase sales.
Song Soo-young, CEO of Huons, noted, "The two types of lidocaine injection products approved by the U.S. FDA are significant as they are highly versatile multi-dose vials, and through this approval, we will solidify our position in the North American market based on high-quality local anesthetics across multiple product lines."