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  • FDA approves Huons' two Lidocaine Inj products
  • by Lee, Seok-Jun | translator Alice Kang | May 8, 2025 06:08am
local anesthetic products 
The 1% and 2% multi-dose vials receive approval as 6th and 7th FDA ANDA approvals, respectively

Huons has received U.S. Food and Drug Administration (FDA) approval for two of its lidocaine local anesthetic products, marking its expansion into the North American market.

On the 7th, Huons (CEO Soo-young Song) announced that it has obtained FDA approval for its ¡°1% Lidocaine 200 mg/20 mL¡± and ¡°(2% Lidocaine 400 mg/20 mL multi-dose vial¡± on the 5th (US local time).

The multi-dose vial products that were granted marketing authorizations this time are formulations that add a preservative to the previously approved lidocaine injection to enable multiple uses after opening.

Huons submitted the application in January and received approval in just 4 months. Like the previously approved 1% and 2% lidocaine h
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