Huons gains approval from FDA for anesthetic drug

Huons, a leading local drug maker, has gained approval for its anesthetic drug from the U.S. Food and Drug Administration (FDA), the company announced Monday.

The Seongnam, Gyeonggi company won the permission for its 2 percent Lidocaine injection 5 milliliter ampoule after filing an application called Abbreviated New Drug Application to the U.S. regulator last December.

The drug maker said that the regulatory approval could help it boost presence in the U.S. market, following FDA’s approval for four other injectable drugs manufactured by Huons.

Sales of the four products reached 12.3 billion won ($9.6 million) in the United States last year, up 69 percent compared to the previous year.

To meet the rising demand for anesthetic injections, Huons is ramping up production capacity at its plants in Jecheon, North Chungcheong, which became a vanguard for exporting injectable products to the U.S. market.

It invested 24.5 billion won into the second plant in Jecheon with an aim of tripling annual capacity from the current level.

The new production line will be up and running by the second half of 2025, according to Huons.

BY PARK EUN-JEE [park.eunjee@joongang.co.kr]