1% and 2% multi-dose vials approved as the company’s 6th and 7th FDA ANDA products
[by Kang, In Hyo]Huonsannounced on May 7 that the company received FDA Abbreviated New Drug Application (ANDA) approvals for 1% (200 mg/20 mL) and 2% (400 mg/20 mL) multiple-dose vials for lidocaine hydrochloride injection on May 5th (local time).
The approved multi-dose vials can be used multiple times after opening, with added preservatives to the company’s already FDA approved 카지노 바카라 hydrochloride injection.
Huons filed its applications in January and received approvals in four months. Same as the company’s already approved 1% and 2% 5mL single-dose vials for 카지노 바카라 hydrochloride injection, Huons confirmed the therapeutic equivalence to the reference listed drug of xylocaine injection.
With the addition of 1% and 2% multi-dose vials for 카지노 바카라 hydrochloride injection, the company now has seven FDA approved products.
Previously, Huons has obtained FDA approvals for five injectable products: △ 0.9% Sodium chloride injection (July 2017) △1% 카지노 바카라 hydrochloride injection 5mL ampoule (April 2018) △0.75% Bupivacaine hydrochloride injection 2mL ampoule (December 2019) △1% 카지노 바카라 hydrochloride injection 5mL vial (May 2020) △2% 카지노 바카라 hydrochloride injection 5mL vial (June 2023). Among them, Huons has also received approvals for three products, including the 0.75% Bupivacaine hydrochloride injection from Health Canada, which are now being exported to Canada.
Huons plans to focus on expanding exports to North America. In North America, the market size for 카지노 바카라 is estimated approximately 500 billion Korean won. The company plans to secure strong sales by fully operating the new production line for injection at the second plant in Jecheon in the second half of this year.
Huons’ CEO Song Soo-young said, “The US FDA approvals of the 1% and 2% multi-dose vials for 카지노 바카라 hydrochloride injection are significant milestones- our 6th and 7th products approved in the US and strong additions to our robust US portfolio. It is especially meaningful in that this multi-dose vial can be highly utilized. Huons looks forward to building a strong foothold in the North American market by offering top quality local anesthetics in various product lines.”