Huons Receives US FDA Approval for Injectable Finished Product... Three Consecutive Years of Success

[Asia Economy Reporter Cho Hyun-ui] Huons' 0.75% Bupivacaine Hydrochloride Injection has obtained approval from the U.S. Food and Drug Administration (FDA). This marks the third achievement following saline solution in 2017 and lidocaine injection in 2018.

Huons announced on the 2nd that it received generic drug approval (ANDA approval) from the FDA on the 30th of last month for the '0.75% Bupivacaine Hydrochloride Injection 2mL ampoule.'

Bupivacaine Hydrochloride Injection is one of Huons' key products in the local anesthetic injection category. Huons succeeded in obtaining this approval by demonstrating bioequivalence with the reference drug 'Hospira.'

According to the FDA, the 0.75% Bupivacaine Hydrochloride Injection 2mL ampoule has experienced a continuous increase in demand within the United States, leading to supply shortages since February 2018. Huons plans to quickly pursue export product approval to resolve the local supply shortage and aims to strengthen its influence in the local anesthetic market alongside the already launched 1% Lidocaine Injection 5mL in the U.S.

Yoon Sung-tae, Vice Chairman of Huons Global, stated, "We will proceed with FDA approval procedures and U.S. cGMP approval for two additional local anesthetic products preparing to enter the U.S. market," adding, "We will promote the excellent quality of Korean-made injections in the global market."

This content was produced with the assistance of AI translation services.