Huons made an announcement on May 8 that it has obtained an item permission (ANDA approval) for lidocaine hydrochloride injection USP, 1%, 50mg/5mL(10mg/mL) from the U.S. FDA.
Huons had previously obtained FDA approval for three ampoule injections (saline solution injection in 2017, lidocaine injection in 2018 and bupivacaine injection in 2019).
The approval marks the first time that the company has obtained a vial standard license, and expects to make it easier to obtain U.S. permits for various injections produced on the vial line in the future.
The approved "1% lidocaine hydrochloride injection 5mL vial" is a vial-standard product of the 1% lidocaine injection 5mL ampoule approved by FDA ANDA in 2018.
The approval confirmed Huons is a global healthcare company that has won FDA ANDA approval for domestic injections for four consecutive years, and disproved that the quality and competitiveness of the drugs produced by Huons have also reached the world level.
As a result, Huons has further consolidated its position as a company specializing in injections in name and reality that has obtained FDA item approval regardless of the injection production process and production standards.
"Lidocaine injections" are a basic medicine that has been suffering from chronic shortage of supplies in the U.S. since the 2010s.
Huons plans to further strengthen its superior position on the item and expand its influence in the U.S. local anesthetic market along with the lidocaine injections and the bupivacaine injections, while also contributing to the supply of basic drugs in the U.S.
It is also cruising to get FDA approval for one additional local anesthetic product that is preparing to advance into the U.S.
"The U.S. FDA approval is a sign that our company has been recognized for the best quality in the world, and we expect the size of exports of injections to countries other than the U.S.," said Eom Ki-an, CEO of Huons.
"We will be recognized for the technical and quality of Korean injections in the global market, including the increase in the number of injections currently exported to more than 30 countries around the world," he added.
