Hugel Obtains MFDS Approval for 300-Unit Botulinum Toxin Product 'Botulax'

[Asia Economy Reporter Hyungsoo Park] Hugel announced on the 29th that it has received sales approval from the Ministry of Food and Drug Safety for the botulinum toxin preparation ‘Botulax’ 300 units.

Hugel obtained product approval for Botulax 100 units in 2010 targeting the indication of eyelid spasm. Since then, it has additionally received product approvals for 50 units, 150 units, and 200 units. The indications have also been expanded to include glabellar lines, post-stroke upper limb spasticity, pediatric cerebral palsy equinus deformity, and lateral canthal lines (crow's feet).

Botulax has established itself as the number one domestic brand in the Korean toxin market for four consecutive years since 2016. Last year, domestic sales exceeded targets, and it is estimated to have recorded a market share of over 50%.

The dosage of botulinum toxin products is determined by the treatment area and range, and can be selected and used on-site according to the purpose. The approved indications for the 300-unit product are two: post-stroke upper limb spasticity and pediatric cerebral palsy equinus deformity. These require a relatively larger amount of botulinum toxin preparation compared to glabellar lines or crow's feet.

A Hugel official explained, "Botulax has achieved remarkable growth in the domestic market over the past 10 years based on excellent product quality and safety," adding, "We expanded the dosage options considering market needs for indications."

Hugel is conducting clinical trials to expand indications in both aesthetic and therapeutic areas for botulinum toxin preparations, including benign masseter hypertrophy, overactive bladder, and cervical dystonia.

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