MFDS Confirms Cancellation of Medytox's 'Medytoxine' Product Approval (Update)

[Asia Economy Reporter Cho Hyun-ui] On the 18th, the Ministry of Food and Drug Safety announced that it will cancel the product approval for Medytox's botulinum toxin preparation 'Medytoxine' effective on the 25th.

The product approval cancellation targets three Medytoxine products: Medytoxine Injection, Medytoxine Injection 50 units, and Medytoxine Injection 150 units.

Earlier, on April 17th, the Ministry had temporarily suspended the manufacturing, sales, and use of these products and has been proceeding with administrative actions including product approval cancellation.

The Ministry decided to cancel the product approval because Medytox manipulated documents to make it appear as if the approved raw materials were used in the Medytoxine production process despite using different raw materials, falsely recorded potency test results of raw materials and products as meeting standards when they did not, and submitted fabricated data to the Ministry to obtain national batch release approval and sold the products in the market.

Regarding Medytox's violation of the Pharmaceutical Affairs Act by falsifying manufacturing and quality control documents, the Ministry canceled the approval of the three Medytoxine products and imposed a fine of 174.6 million KRW in lieu of a three-month suspension of manufacturing operations on another botulinum toxin product, 'Innotox.'

Additionally, the Ministry ordered Medytox to recall and dispose of the three canceled products and urged medical institutions and others holding the products to actively cooperate with the recall.

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