Hugel Resubmits FDA Approval Application for Botulinum Toxin 'Botulax' in the US

Completed Supplementary Work After Receiving CRL in March This Year

[Asia Economy Reporter Lee Gwan-joo] Hugel announced on the 7th that it has resubmitted a product approval application to the U.S. Food and Drug Administration (FDA) for the botulinum toxin product 'Botulax' (export name Retivo) with an indication for glabellar lines.

Hugel submitted an approval application for Botulax 50 units and 100 units last March aiming to enter the U.S. market, and received a Complete Response Letter (CRL) from the FDA in March this year.

In response to the requirements in the CRL, Hugel completed supplementary work on some literature and data and resubmitted the approval application to the FDA. Since it usually takes about six months from submission to approval, if approved, Botulax is expected to enter the U.S. market in the first half of next year.

Hugel has been making great efforts to enter the U.S. market. In 2020, it recruited James Hartman, who served as Vice President of North American Aesthetic Business at German company Merz, as CEO of Hugel America, which will handle local sales, marketing, and distribution of Botulax. In June this year, Brent Saunders, former CEO and Chairman of global company Allergan (now AbbVie), was elected as chairman of the board.

A Hugel official said, "The U.S. is the largest botulinum toxin market in the world as a single country and is one of the key markets leading Hugel's global leap following China and Europe," adding, "As we enter the final stage of entering the U.S. market, we will do our best to successfully launch locally and establish ourselves as a top 3 toxin brand in the U.S. within three years of market entry."