MFDS Cancels Approval for 5 Medytox Botulinum Toxin Products

[Asia Economy Reporter Cho Hyun-ui] Five products including Medytox's 'Medytoxinjoo' and 'Coretoxjoo' will have their product approvals canceled as of the 20th of this month.

The Ministry of Food and Drug Safety announced on the 13th, "The product approvals for Medytoxinjoo, Medytoxinjoo 50 units, Medytoxinjoo 150 units, Medytoxinjoo 200 units, and Coretoxjoo will be canceled as of November 20."

Earlier, on the 19th of last month, the Ministry temporarily suspended manufacturing, sales, and use of these products due to sales without national batch approval. Subsequently, administrative procedures including product approval cancellation have been underway.

The Ministry stated, "Medytox sold pharmaceuticals subject to national batch approval without such approval, sold to persons not authorized to sell pharmaceuticals, and sold pharmaceuticals violating labeling requirements (no Korean labeling)."

To prevent the use of pharmaceuticals with canceled product approvals, the Ministry ordered Medytox to recall and dispose of pharmaceuticals currently in distribution. They also requested medical institutions storing these pharmaceuticals to cooperate with the recall.

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