Medytox has filed a lawsuit against the Ministry of Food and Drug Safety to suspend the execution of the latter’s order to stop making and selling Meditoxin, as well as cancel the order itself.
Medytox issued a statement on Monday, expressing its position on the ministry’s order to halt the manufacture and marketing of 50 units, 100 units, and 150 units of Meditoxin inj., a botulinum toxin product, temporarily.
Last Friday, the regulator entered into an administrative procedure by temporarily halting the manufacture, sale and use of the three doses of Medytoxin products concerning the “suspicion of manipulating test results,” as well as canceling its item permission.
The Medytoxin case first emerged in 2019, when the prosecution started a probe based on the tipoff to the Korea Anti-Corruption & Civil Rights Commission from a former Medytoxin employee who was working at Daewoong Pharmaceutical at the time.
According to the tipoff, Medytox used ingredients without a change of permission for some Meditoxin products manufactured from December 2012 to June 2015.
The regulator’s actions were based on Article 71 of the Pharmaceutical Affairs Act, referring concerns over current public health. However, the period related to the “Meditoxin issue” was from December 2012 to June 2015. All the Meditoxin products made during the period were used, and none of them exist. Therefore, no harm to public health can currently exist, according to the statement.
Medytox said the company had not received reports of any severe adverse effects from using 16.9 million vials (100 unit equivalents) of Medytoxin products from its market launch in 2006 to 2019.
The Meditoxin products that are being distributed now were made after April 2017. Medytox received a conformity decision in 2016 and 2018 when the ministry collected products in circulation and inspected them. They also showed no problems in numerous inspections with stringent observations and random collections of distributed products in terms of efficacy and safety, the company claimed.
This notwithstanding, Medytox plan to focus on producing other botulinum toxin products, Innotox, and Coretox, discontinuing the manufacture and sales of Meditoxin in keeping with the ministry’s order, it added.
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