Medytox won a final victory in an administrative lawsuit against the Ministry of Food and Drug Safety, which canceled product approval and ordered a stop to manufacturing and selling the botulinum toxin (botox) product 'Medytoxin,' claiming it was produced with unapproved raw materials.
According to industry sources on the 13th, the Supreme Court's Special 1st Division dismissed the Ministry's appeal in the case concerning the cancellation of product approval and stop of manufacturing for three Medytoxin products (50, 100, 150 units) that Medytox filed against the head of the Daejeon Regional Food and Drug Administration.
As a result, following the first and second trials, the Supreme Court also ruled in favor of Medytox, canceling all product approval cancellations.
Earlier, the Ministry of Food and Drug Safety canceled the product approval for three items on June 3, 2020, stating that Medytox manufactured and sold the wrinkle improvement product Medytoxin with unapproved raw materials and falsely recorded that it produced the approved raw materials using different ones.
In response, Medytox filed a lawsuit to cancel the administrative disposition, arguing that the raw materials had not changed and that the safety and efficacy were unaffected by some manufacturing method changes, making the cancellation excessively harsh.
Separately, Medytox is also pursuing a lawsuit to challenge the cancellation of approval and stop order for 'Medytoxin' and 'Coretox' issued by the Ministry for selling export botox products without national release approval. It has won in the first and second trials and is currently awaiting the Supreme Court's judgment. There is also an ongoing case at the Daejeon District Court regarding allegations of manipulating safety test data during the approval process for 'Innotox,' with prosecutors applying charges of obstructing public duty.