Hugel Challenges FDA Approval for 'Botulex' in the US for the Third Time... Resubmits Application for FDA Approval

Received CRL from FDA in April
Completed factory equipment and partial data·literature supplementation
"Expected to obtain product approval in Q1 next year"

Hugel announced on the 1st that it resubmitted an application for product approval to the U.S. Food and Drug Administration (FDA) on the 31st of last month (local time) for its botulinum toxin (BTX) formulation "Retivo" (domestic product name Botulex) 50 units and 100 units, with the indication for glabellar lines.

Hugel's botulinum preparation 'Botulax Injection'.
[Photo by Hugel]

Previously, Hugel applied for product approval for two Retivo products in October last year and received a Complete Response Letter (CRL) from the FDA in April. Accordingly, Hugel completed supplementary work on factory facilities and some data and literature based on the CRL contents and resubmitted the approval application.

Since it takes about six months from submitting documents to the FDA to obtaining approval, Hugel expects to acquire product approval for Retivo within the first quarter of next year.

This is Hugel's third application for BTX formulation product approval in the U.S. market. Earlier, Hugel submitted its first Biologics License Application (BLA) in March 2021 and received a CRL from the FDA in March last year. At that time, the FDA requested additional supplementation of literature and data regarding the facilities added to the factory and approval matters after the BLA submission. Hugel supplemented these and reapplied for the BLA to the FDA in October last year but received a second CRL in April. The second CRL is known to contain issues related to factory management.

A Hugel official said, "The U.S. is the largest BTX market in the world among single countries and is considered one of the global big three markets along with China and Europe, where we have already entered," adding, "We will do our best to successfully enter the U.S. market and help Hugel leap forward as a leading company in the global toxin industry."

Meanwhile, Retivo is the number one product in the domestic BTX market and was the first to be launched in local markets in China, Europe, and Australia. Canada, which obtained product approval in June last year, is also preparing to launch the product within this year.

This content was produced with the assistance of AI translation services.