Huons’ 2% lidocaine gets approval from FDA

South Korean pharmaceutical firm, Huons Co., announced on Monday that it has secured another significant regulatory milestone in the US with the Food and Drug Administration's (FDA) approval for the Abbreviated New Drug Application (ANDA) for its 2% lidocaine injection 5mL vial.

Lidocaine is a local anesthetic frequently utilized in dermatology procedures and cosmetic surgery. The injectable local anesthetic demonstrated bioequivalence to its reference drug, which paved the way for its approval.

This FDA approval signifies Huons' fifth major accomplishment in the US regulatory landscape. The company previously obtained approval for four other products: a physiological saline injection in 2017, a 1% lidocaine hydrochloride injection 5mL ampoule in 2018, a 0.75% bupivacaine hydrochloride injection 2mL ampoule in 2019 and a 1% lidocaine hydrochloride injection 5mL vial in 2020. Moreover, the 1% lidocaine local anesthetic also received the green light for distribution in Canada this past February.

Huons intends to use this approval as a springboard to advocate for the high quality of South Korean local anesthetics and to significantly contribute to the consistent supply of lidocaine in North America, where there has been a chronic shortage.

Looking ahead, the company plans to concentrate on expanding exports to the North American market. Its four FDA-approved ANDA products, including the lidocaine local anesthetic, have recorded strong sales growth of approximately 12.3 billion won ($9.58 million) in the US, marking a 69% year-on-year increase.

Huons is also investing heavily in increasing its production capacity to meet the growing demand for its injectable products overseas. The company is pouring 24.5 billion won into expanding vial and cartridge injection production lines at its second plant in Jecheon, located about 120 km south of Seoul in North Chungcheong Province.

Upon completion, the new vial line will triple the current capacity to approximately 79 million vials, and the cartridge line will enhance its production by 1.5 times to 210 million cartridges. The facility is anticipated to be fully operational by the second half of 2025.

Write to Hyun-Ah Oh at 5hyun@hankyung.com