Medytox 'Medytoxyn' Additional Hearing to Be Held

[Asia Economy Reporter Cho Hyun-ui] Medytox will hold an additional hearing next month ahead of the cancellation of the domestic botulinum toxin product 'Medytoxine' approval.

A lawyer from the law firm Hwawoo, representing Medytox, stated on the 22nd, "We decided to continue the hearing on June 4th because additional testimony from experts and submission of materials and procedures are necessary."

The Ministry of Food and Drug Safety (MFDS) previously held a hearing at the Daejeon Regional Food and Drug Administration in the afternoon to hear the manufacturer Medytox's opinion regarding the administrative disposition to cancel the approval of Medytoxine. A Medytox official said, "It seems that the additional hearing was scheduled based on the explanations provided during the hearing."

Medytox reportedly made active explanations during the approximately three-hour hearing held that day. The Korean Society of Aesthetic Dermatology also sent a petition to the MFDS stating that "the cancellation of Medytoxine's approval is harsh."

Last month on the 17th, the MFDS judged that Medytox violated the Pharmaceutical Affairs Act by manufacturing and selling Medytoxine in violation of approval conditions and raw material standards, and initiated the procedure to cancel the product approval. The products in question are Medytoxine Injection 150 units, 100 units, and 50 units.

Medytox believes the MFDS's action lacks sufficient grounds. Considering that the MFDS's administrative procedure takes some time, a provisional manufacturing and sales suspension was issued first, but the products were produced between December 2012 and June 2015 and are no longer available. Medytox stated, "The MFDS order presumes a 'public health hazard,' but the products were already exhausted long ago and no longer exist," adding, "At this point, there can be no public health hazard."

Meanwhile, the court recognized an urgent need to suspend the execution of the manufacturing and sales suspension order in the appeal case filed by Medytox against the head of the Daejeon Regional Food and Drug Administration on the same day.

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