Court Overturns License Revocation for Medytox’s Botulinum Toxin Product

Reporter Kim Jisun / approved : 2024-09-11 03:35:17
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Medytox.(photo=medytox)

 

[Alpha Biz= Reporter Kim Jisun] A court ruling has ordered the cancellation of the revocation of the product license and manufacturing suspension for Medytox's botulinum toxin product, "Medytoxine."

On the 10th, Medytox, a biopharmaceutical company, announced that the Daejeon High Court's Administrative Division No. 2 had dismissed the appeal filed by the Ministry of Food and Drug Safety (MFDS) regarding the cancellation of Medytoxine’s product license. Medytoxine is a botulinum toxin used in cosmetic procedures.

In 2020, the MFDS concluded that Medytox had used unauthorized raw materials during the production of Medytoxine between 2012 and 2015 and had falsified documents to make it appear as though they had used authorized ingredients. As a result, the MFDS revoked the product licenses for three versions of Medytoxine (50, 100, and 150 units).

However, Medytox contested the severity of the decision, filing a lawsuit to overturn the MFDS’s ruling and also requesting a suspension of enforcement. The company argued that although some manufacturing processes had changed, the raw materials had not, and there were no issues with the product’s safety or efficacy.

With the suspension granted, sales of the product were not halted. In June, the court of first instance ruled that the revocation of the product license and the suspension of manufacturing and sales should be overturned. The MFDS appealed this decision, but the appeal was dismissed in this latest ruling.

 

 

Alphabiz Reporter Kim Jisun(stockmk2020@alphabiz.co.kr)

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