"Cancellation of Botulinum Product Approval" Zetema's Legal Response... "Injunction Effective Until January 20 Next Year"

[Photo by Jetema website]

[Asia Economy Reporter Lee Gwan-ju] Zetema has begun legal action after receiving a cancellation of product approval for export-use botulinum toxin from the Ministry of Food and Drug Safety.

On the 6th, Zetema announced through its website, "On the 2nd, we immediately filed an objection and requested a provisional suspension of the cancellation of product approval and manufacturing suspension order issued by the Ministry of Food and Drug Safety," adding, "On the 5th, we received a court ruling suspending the effect of the cancellation of product approval, six-month manufacturing suspension, recall and disposal order, and recall announcement order until January 20 of next year."

Following the court's decision, Zetema added that it immediately resumed manufacturing and sales of the export-use product 'Zetema The Toxin Injection 100U.' Furthermore, it stated, "We will consult with the Ministry of Food and Drug Safety regarding this issue, which arose due to differences in interpretation of the indirect export method that does not involve domestic sales."

Previously, the Ministry of Food and Drug Safety imposed cancellation of product approval and manufacturing suspension on Zetema, Korea BNC, and Korea BMI for violating national batch release approval of botulinum toxin preparations.

In response, Zetema rebutted, "This product is a toxin drug approved for export by the Ministry of Food and Drug Safety in June 2020, and all units are exported. Additionally, it is a product undergoing domestic Phase 3 clinical trials, so the national batch release approval claimed by the Ministry of Food and Drug Safety cannot fundamentally be obtained and is not subject to violation of the Pharmaceutical Affairs Act."