The Ministry of Food and Drug Safety (MFDS) said it has appealed against the first-instance court decision that canceled the sales suspension of Meditoxin, Medytox's botulinum toxin (BTX) product.

The Ministry of Food and Drug Safety appealed the first-instance court's decision to revoke the MFDS' order to cancel the product approval of Meditoxin, Medytox's botulinum toxin product.
The Ministry of Food and Drug Safety appealed the first-instance court's decision to revoke the MFDS' order to cancel the product approval of Meditoxin, Medytox's botulinum toxin product.

The MFDS decided to appeal under the direction of the Ministry of Justice, believing that further response is needed regarding the facts of the case in a higher court.

While the first-instance court found that the MFDS' decision to revoke the product license was an abuse of discretion, the MFDS stated its intention to earnestly respond based on relevant evidence regarding the appropriateness of the product license revocation in the appellate court.

The legal dispute began in June 2020 when the MFDS found that Medytox had changed the raw materials from 2012 to 2015 without proper reporting and approval. Consequently, the MFDS canceled the product approval for Meditoxin and issued a manufacturing and sales suspension.

Medytox argued that only the manufacturing process was altered, not the raw material, and therefore, said it should only face a one-month suspension. The company filed a lawsuit and suspended execution against the MFDS's cancellation of product approval.

In August 2020, the court granted the suspension of the execution of the product approval cancellation and recall and disposal orders for Meditoxin.

As a result of Medytox’s lawsuit against the MFDS, the Daejeon District Court ruled in favor of Medytox on Nov. 9.

In detail, the court ordered the cancellation of the MFDS's decision to revoke the product approvals and the suspension of manufacturing and sales orders for Meditoxin in all dosages.

In response to MFDS' appeal, a Medytox official said they will earnestly go through the legal procedure to Korea Biomedical Review.

Meanwhile, the appeal had no significant effect on Medytox's stock. As of market close Friday, Medytox's shares stood at 219,000 won ($167), down 0.45 percent from the previous trading day.

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