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March 29, 2024

Huons gets US approval for sodium chloride injection

PUBLISHED : July 24, 2017 - 17:06

UPDATED : July 24, 2017 - 17:06

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[THE INVESTOR] Korea’s biotech firm Huons said on July 24 it has received approval from the US Food and Drug Administration for its abbreviated new drug application for sodium chloride injection.

The company said the FDA nod came as its 0.9 percent sodium chloride injection 5mL/10mL was similar to the biological reference product developed by US drug maker Hospira. 




“The green light enables Huons to export the product to the US in earnest, and also offers global recognition for the company’s quality of products and injection equipment production facilities,” the firm said in a release.

The injection will be produced at the company’s first cGMP plant in Jaechun, North Chungcheong. Its second production site, dedicated to botulinum toxin products, is under construction.

A Huons official told The Investor that the company has not yet decided on selling the sodium chloride injection via a local marketing partner.

“We still need to figure out some details including searching for a partner and setting the US launch date,” she said.

Sodium Chloride injection is given to patients who have low levels of sodium or chloride, which are naturally present in body fluids and are needed for normal body function. It is also used for the dilution of other medicines before injection into the body.

Meanwhile, the company said it will continue to seek US approval for its lidocaine injection which treats severe joint pain caused by different types of arthritis, including osteoarthritis.

By Park Han-na (hnpark@heraldcorp.com)

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