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Medytox(174,700 -7.91%)Announced that it will take legal action in connection with the initiation of the procedure for canceling the product license of Innotox by the Ministry of Food and Drug Safety.
On the 23rd, Medytox said, “We will immediately file a lawsuit for suspension of execution and cancellation of the order to suspend the provisional manufacturing and sale of Daejeon Food and Drug Administration against Innotox. I will make an active call through it.”
The Ministry of Food and Drug Safety said that the day before, it has initiated administrative disposition procedures such as cancellation of product permission from Innotox. In addition, considering that the administrative procedure for revocation of the permit takes time, the company ordered the manufacture and sale of Innotox to be temporarily suspended.
This disposition is based on the results of the prosecution’s investigation into Innotox’s suspicion of manipulation of documents for permission submission, which was reported to the National Rights Commission of Korea in April. The prosecution confirmed the violation of falsifying safety test data in the process of permitting drug product approval and modification by a company, and prosecuting it for obstructing the execution of public affairs by hierarchies under Article 137 of the Criminal Act.
The Ministry of Food and Drug Safety may revoke the product license if the drug product license has been obtained through false or other illegal methods. Accordingly, Innotox started the procedure for canceling the item permission.
Medytox said, “I sincerely apologize to customers and shareholders who are concerned about a lot from the disposition of the Ministry of Food and Drug Safety.”
In addition, he explained that the botulinum toxin formulation, which was technically exported to Allergan in 2013, was a separate product from Inotox. The technology exported medicines are in the final stage of phase 3 clinical trials, and they are planning to apply for marketing approval next year.
It also said that the disposition is not related to the lawsuit against Daewoong being held by the US International Trade Commission (ITC).
Reporter Minsoo Han [email protected]
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