Hugel resubmits BLA for its botulinum toxin, Botulax to the U.S. FDA

• Hugel received CRL from the U.S. FDA last March and completely supplemented documents and data.
• It is expected to obtain the U.S. FDA's approval in the first half of 2023 and aims to become a TOP 3 botulinum toxin brand in the U.S. market.

SEOUL, South Korea, Oct. 7, 2022 /PRNewswire/ -- Hugel (CEO Jihoon Sohn), a global total medical aesthetics company, announced that it resubmitted the BLA for its botulinum toxin called Botulax on October 6^th (local time), for the indication of glabellar lines to the U.S. FDA.

Hugel had received a Complete Response Letter (CRL) from the U.S. FDA last March after submitting the BLA for Botulax (50 and 100 units) in order to advance into the U.S. market in March of last year.

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