MFDS Cancels Meditoxin Approval... Meditox States "Not Subject to Disposition"

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety (MFDS) confirmed that Medytox sold the botulinum toxin preparation 'Medytoxine' without quality inspection such as national batch release approval, and on the 19th ordered the recall and disposal of the product. Medytox opposed this and announced that it would file an administrative lawsuit and request a suspension of execution.

According to the MFDS, Medytox violated the Pharmaceutical Affairs Act by selling botulinum toxin preparations, which are subject to national batch release approval, without obtaining such approval or by violating labeling regulations.

The products in question are Medytoxine (50, 100, 150, 200 units) and some Coretox products that were sold without national batch release approval or in violation of labeling regulations. The MFDS plans to recall and dispose of these products.

The MFDS plans to cancel the marketing authorization of the related products for selling botulinum toxin preparations without national batch release approval, and to impose suspension of sales operations for selling pharmaceuticals to unauthorized persons and for selling pharmaceuticals without Korean labeling.

Considering the time required for the cancellation procedure, the MFDS ordered a provisional suspension of manufacture and sales of Medytoxine and Coretox to protect consumers. A safety alert requesting immediate cessation of use was distributed to hospitals and clinics.

Medytox opposed the MFDS's decision, stating, "The MFDS decided to cancel the approval by judging pharmaceuticals produced for export as for domestic sales."

According to the company, pharmaceuticals produced for export are not subject to national batch release approval by the MFDS under the Pharmaceutical Affairs Act. In fact, other domestic companies manufacturing and selling botulinum toxin preparations also sell export pharmaceuticals without national batch release approval procedures.

Medytox stated, "The MFDS's application of the Pharmaceutical Affairs Act to export pharmaceuticals is clearly illegal and unfair," and "We will immediately file a lawsuit to cancel the administrative disposition and request a suspension of execution."

Medytoxine was the first domestically produced botulinum toxin preparation to receive MFDS approval in 2006. The botulinum toxin preparation, also known as Botox, is used in cosmetic procedures such as improving glabellar lines.