Hugel resubmits application to FDA for botulinum toxin product
In-hyuk Park
Sep 01, 2023 (Gmt+09:00)
South Korea's biopharmaceutical company Hugel Inc., announced on Friday that it has resubmitted applications to the US Food and Drug Administration (FDA) for the product approval of its botulinum toxin preparations "Letybo" (marketed domestically as Botulax) in 50 units and 100 units for the indication of glabellar lines.
The company applied in Oct. last year for product approval for these two products with the FDA and received in April this year a complete response letter.
According to Hugel, the company has completed the necessary enhancements related to facility equipment, some data, and documentation as per the FDA's requirements and has resubmitted the application. The company anticipates that the approval status for the product could be confirmed within the first quarter of next year, considering an approximate six-month evaluation period.
Hugel states that Letybo is the leading botulinum toxin product in the domestic market, and it was the first among domestic companies to be launched in markets such as China, Europe, and Australia. In Canada, the product obtained approval in June of last year and is set to be launched later this year.
"The US holds the world's largest market for botulinum toxin," a Hugel source said. "Successfully settling in the US market would propel our company to become a leading player in the toxin industry."