[단독] Medytox Botox, which has been discontinued, can be sold again

Medytox will be able to resell three items of its flagship product, Botolinum Toxin (Botox).

On the 8th, the first administrative department of the Daejeon Regional Administrative Court decided to suspend the application for suspension of execution of item permission, etc., filed by Medytox against the head of the Daejeon Regional Food and Drug Administration. In response to the government’s order for cancellation of product permission, collection, disposal, and retrieval of Innotox last month, the court decided that Botox could be sold until 30 days after the date of final sentencing. Innotex is the world’s first liquid Botox formulation developed by Medytox.

The Ministry of Justice suspended the enforcement of the effect by the Ministry of Food and Drug Safety, saying, “It is recognized that there is an urgent need to prevent damages that are difficult to recover from the applicant (Meditox), and there is no data to admit that there is a concern that there is a risk of serious impact on public welfare due to the suspension of execution.” .

Accordingly, Medytox emerged from the risk of canceling product licenses for three Botox formulations. All three items can be sold immediately from the 8th. The court will decide whether it is illegal in earnest through the main lawsuit.

On the 19th of last month, the Ministry of Food and Drug Safety (Ministry of Food and Drug Safety) stopped manufacturing and selling Innotox and canceled the product license. This is because Medytox judged that the safety test data were forged in the process of drug product/modification approval. The stability test is a quality test conducted to set the storage method and duration of use of the drug. Here, if permission for product or modification is obtained in an illegal manner, the government may revoke the permission for product in accordance with the Pharmaceutical Affairs Act.

In October of last year, the Ministry of Food and Drug Safety issued the same disposition for Meditoxin and Coretox, another Botox formulation of Medytox. It is suspected of selling products for export without obtaining approval for national shipment. Medytox filed a lawsuit with the Daejeon District Law for the cancellation of the license for Medytox and Coretox products, and the execution was suspended until the main lawsuit was sentenced. Medytoxin is a freeze-dried Botox formulation, while Coretox is a Botox formulation that reduces the risk of resistance development by removing non-toxin proteins.

Regarding the decision on the day, Medytox said, “The court ruling made it possible to sell Botox products normally.” “We will focus our efforts on normalizing management.”

Reporter Moon Hee-cheol [email protected]