The First Domestic Native Botox 'Medytoxine' Banned

MFDS Cancels Approval of Medytox for Document Manipulation

[Asia Economy Reporters Choi Dae-yeol and Jo Hyun-ui] The botulinum toxin preparation 'Medytoxine,' the first domestically developed product to receive approval, has been withdrawn from the market. This follows the discovery of document forgery during investigations and inquiries by authorities. As a product commonly known as 'Botox,' it accounts for about 40% of the sales of Medytox, the leading domestic company, so the company is expected to suffer significant damage.

On the 18th, the Ministry of Food and Drug Safety announced that it would cancel the approval of three Medytox products?Medytoxine Injection and Medytoxine Injection 50 and 150 units?effective on the 25th. The ministry had issued a provisional suspension of manufacturing, sales, and use in mid-April and has since been carrying out administrative procedures to revoke the product approvals for over two months. Although the problematic products do not pose significant safety issues, the ministry explained that it took firm action because acts such as document forgery and deceiving regulatory authorities could negatively impact the entire domestic pharmaceutical and bio-industry.

With this measure, the product, which was first approved as a domestic Botox in 2006, has been driven out of the market after 14 years. Along with the cancellation of Medytoxine's approval, the company’s other product, 'Innotox Injection,' was fined 174.6 million won as a substitute for a three-month suspension of manufacturing operations. Since the withdrawn products held nearly half of the domestic Botox market share, it is expected that later entrants will actively seek to expand their market presence.

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