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Innotox, a wrinkle-improving botulinum formulation produced by Medytox, has been temporarily suspended from manufacturing, sales, and use on the 22nd. In addition, the Ministry of Food and Drug Safety announced that it has initiated administrative disposition procedures such as cancellation of product permission.
Currently, there are three botulinum formulations sold by Medytox: Medytox, Inotox, and Coretox. However, four doses of Medytoxin (50 units, 100 units, 150 units, 200 units) and Coretox were subject to cancellation of product approval in November. Subsequently, the cancellation of the product license to Innotox was decided, and all of Medytox’s botulinum toxin products were in danger of disappearing from the market.
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 forged 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.
Accordingly, the Ministry of Food and Drug Safety initiated the procedure for revoking the product license of Innotox pursuant to Article 76 (1) 2-3 of the Pharmaceutical Affairs Act that it may cancel the product license if the drug product license is obtained through false or other illegal methods. did. 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.
Reporter Jiwon Choi [email protected]
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