Huons, a Korean pharmaceutical company, said on Thursday the US Food and Drug Administration has approved its 5ml ampule injection of 1 percent lidocaine for use as local anesthetics.

The approval is based on the results of a bioequivalence study that compared the generic formulation to reference drug Xylocaine Injection from Fresenius Kabi, the Kosdaq-listed firm said in a regulatory filing.

Huons shares opened up 4 percent Friday morning but ended the day 5.92 percent down at 112,900 won ($105.78) on profit-taking.

The company pitched that it is the only maker licensed to sell the formulation across the U.S., where supply shortages have been reported after market monopoly Hospira cut its production. Demand for lidocaine anesthetic is estimated at 600 billion won in the United States.

Huons already received 13 million ampules in preorders from its American partner Spectra.

The U.S. topical and local anesthetics market is valued at around $2 billion, of which roughly one quarter is represented by lidocaine.

“The FDA approval will be helpful to our export of lidocaine injection products to the U.S. and we will seek to obtain an FDA license for other major products in our portfolio,” said the company’s spokesman.

By Kim Hye-soon and Minu Kim

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]