Cancellation of Meditoxin Approval, Suspension of Effectiveness Until the 14th of Next Month

[Asia Economy Reporter Choi Dae-yeol] The court has accepted the company's request to suspend the cancellation of the domestic botulinum toxin product "Medytoxine" until mid-next month.

According to the related industry on the 24th, the 1st Administrative Division of the Daejeon District Court decided yesterday to temporarily suspend the effect of the cancellation of the product license recently issued by the Ministry of Food and Drug Safety. Previously, the Ministry of Food and Drug Safety made a decision to cancel the product license on the 18th, citing "document forgery," and the official effect was scheduled to take place from the 25th. In response, Medytox, which produces and sells Medytoxine, filed a provisional injunction to suspend the effect of the decision and a lawsuit to cancel the decision on the same day.

This court decision temporarily suspends the effect of the cancellation to determine whether to accept Medytox's provisional injunction application. The court stated, "The effect of the cancellation of Medytox's Medytoxine product license, recall and disposal, and the order to announce the recall issued by the head of the Daejeon Regional Food and Drug Administration on the 18th will be suspended until July 14."

The Ministry of Food and Drug Safety viewed that Medytox violated regulations by using unauthorized raw materials and falsifying documents during the production of Medytoxine from 2012 to 2015. Accordingly, the licenses for three products, including Medytoxine injection, were canceled. The cancellation of the product license means market withdrawal. The company has acknowledged some violations but stated that since there are no issues with safety and efficacy, the cancellation is excessive and intends to resolve the matter through litigation.

Botulinum toxin products, commonly known as Botox, are widely used not only for therapeutic purposes such as strabismus and blepharospasm but also for cosmetic purposes like improving glabellar wrinkles. Botox is a brand developed by Allergan in the United States, and Medytox was the first domestic product to receive approval in Korea in 2006. The three products whose licenses were canceled, including Medytoxine, reportedly account for about 40% of the company's sales.

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