MFDS Cancels Marketing Authorization for Medytox's 'Innotox Injection'

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety announced on the 18th that it will cancel the approval of Medytox's botulinum toxin preparation 'Innotox Injection' as of the 26th due to violations of the Pharmaceutical Affairs Act by obtaining the product approval and change approval through false or fraudulent means.

The Ministry ordered Medytox to recall and dispose of the distributed pharmaceuticals to prevent the use of the product whose approval has been canceled. Medical institutions and others storing the product were requested to actively cooperate with the recall.

The Ministry confirmed, based on the prosecution investigation results, that the company forged safety test data during the process of obtaining product approval and change approval for the pharmaceutical. Accordingly, on December 22 of last year, it temporarily suspended the manufacture, sale, and use of the product and has been proceeding with administrative measures such as canceling the product approval.

The Ministry stated, "We will continue to strictly crack down and punish acts that threaten public health with a zero-tolerance policy and will guide and inspect the industry to ensure compliance."