Huons said Thursday that it has received approval of the company’s abbreviated new drug application (ANDA) from the U.S. Food and Drug Administration (FDA) for 1-percent Lidocaine 5mL amp., a local anesthetics.
The approval comes after the company proved the drugs biologically equivalence when compared to 1-percent Xylocaine, a reference product, manufactured from Fresenius Kabi USA.
With the FDA authorization, Huons is now the sole supplier of lidocaine injections in the U.S. According to the FDA’s Drug Shortages Database, the U.S. has been suffering from lidocaine injections after the two existing FDA approved companies stopped supplying the drug. In the past, Hospira and Fresenius Kabi USA had a monopoly on the U.S. lidocaine market.
The company now plans to supply the product nationwide in the U.S.
Spectra, Huons’ supplier in the United States, have pre-ordered 13 million lidocaine amp. The company expects more orders shortly as the pre-order amount is already close to the first and second batch of orders stated in the contract signed by the two companies in 2010.
“The ANDA approval of the lidocaine is significant as it is the second such go-ahead for the company after receiving one for our sanitary infusion in July last year,” Huons Global Vice Chairman Yoon Sung-tae said. “The approval has again proved the quality of our products and the state-of-the-art injection production facility to the world.”
The company plans to continue applying for ANDA on its injection products such as vials in the future while strengthening its position as a global healthcare company by generating higher sales as the only lidocaine injection registered in the U.S., Yoon added.
According to Grand View Research, a U.S. based market research company, the local anesthetics market in the country reached 2 trillion won ($1.88 billion) in 2016. Of the 2 trillion won, the market share for lidocaine is about 600 billion won.
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