A local court on Wednesday has turned down Medytox's appeal for suspending the execution of the government’s order to stop making and selling three of its botulinum product lineup, Meditoxin.
|The Daejeon District Court dismissed Medytox's application for suspending the administrative order's execution for revoking the sales license on Meditoxin. (Medytox)|
The Daejeon District Court on Thursday dismissed Medytox's application for suspending the execution of the administrative order issued by the head of the Daejeon branch of the Ministry of Food and Drug Safety, according to industry sources.
With the court's decision, the Ministry of Food and Drug Safety's decision to cancel the Meditoxin product approval will go into effect.
Last month, the ministry said it would revoke the sales license of Medytox’s botulinum toxin product Meditoxin for fabricating test data on June 18. It then revoked the sales license of three of the company's products – Meditoxin, Meditoxin 50 unit, Meditoxin 100 unit – and imposed a fine of 174.6 million won ($143,550) on Innotox.
Medytox in part admitted the violations of the Pharmaceutical Affairs Law but filed an administrative lawsuit insisting that the cancellation of the product license was too harsh, claiming there are few problems with the drug’s safety and effectiveness.
The company said it would appeal the court's decision immediately.
"We will appeal the decision to the Daejeon District Court," a company official said. "However, our specific schedule has not been set."
The Ministry of Food and Drug Safety notified the 49 countries around the world that they had revoked the approval of three Meditoxin products through the Pharmaceutical Inspection Co-operation Scheme (PIC/S).
The move was following the obligation to notify PIC/S member countries when changes, such as cancellation of permission, have occurred concerning pharmaceuticals.
After the ministry notifies each country, it is up to the respective countries to take subsequent actions.
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