'Medytox' Expulsion Postponed... Suspension of License Cancellation Effective Until Next Month 14

[Asia Economy Reporter Cho Hyun-ui] The approval for the first domestically produced botulinum toxin product, 'Medytoxine,' has once again been suspended until August 14.

On the 14th, the Daejeon High Court decided to temporarily suspend the effect of the Ministry of Food and Drug Safety's cancellation of the approval for three Medytoxine products and the order for their recall and disposal until next month 14. This suspension follows Medytox's appeal to the Daejeon High Court after disagreeing with the Daejeon District Court's ruling on the 9th, which had previously denied the suspension of the cancellation order.

On the 18th of last month, Medytox filed a provisional injunction to suspend the effect of the Ministry of Food and Drug Safety's cancellation of Medytoxine's approval and a lawsuit to revoke the cancellation at the Daejeon District Court. Subsequently, on the 9th, the Daejeon District Court dismissed Medytox's request for suspension of execution. As a result, the Ministry's cancellation decision took effect, but it was temporarily suspended again following the Daejeon High Court's decision on the same day.

Earlier on the 18th of last month, the Ministry of Food and Drug Safety announced its intention to cancel the approval of three Medytoxine products (Medytoxine Injection 50 units, Medytoxine Injection 100 units, Medytoxine Injection 150 units). The Ministry found violations such as the use of unauthorized raw materials and falsification of documents during the production of Medytoxine from 2012 to 2015. Medytox acknowledges some violations but argues that since there are no issues with safety and efficacy, the cancellation is excessive.

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