The Ministry of Food and Drug Safety temporarily banned the manufacture, sales, and use of Medytox's botulinum toxin Innotox and began preparation to revoke its approval on Tuesday.

The move comes after the ministry canceled the permission of the company's 50, 100, 150, and 200 units of Meditoxin and 100 unit of Coretox, Medytox’s two other BTX products used as aesthetic medicines, on Nov. 13.

The Ministry of Food and Drug Safety has decided to revoke the approval of Medytox’s wrinkle treatment Innotox for violating the Pharmaceutical Affairs Act.
The Ministry of Food and Drug Safety has decided to revoke the approval of Medytox’s wrinkle treatment Innotox for violating the Pharmaceutical Affairs Act.

However, the ministry’s previous disposition on the two products had been suspended for 30 days since the Daejeon District Court cited Medytox's appeal and reversed the ministry's license revocation on Nov. 27.

According to the ministry, regulators made the decision based on the results of the prosecution's investigation into the allegation that Medytox manipulated documents to win approval for Innotox injection.

The prosecution confirmed that Medytox forged safety test data in changing approval for the drug, accusing the company of obstructing official duties under Article 137 of the Criminal Act.

Innotox is the world's first liquid injectable BTX product ever developed by Medytox.

Ministry officially confirmed that Medytox had violated the regulations to obtain item permission and permission for change concerning Innotox, based on the prosecution’s notification.

"We have temporarily suspended manufacture and sales of Innotox to protect consumers from possible harmful effects, and notified healthcare providers, Health Insurance Review and Assessment Service and related bodies of our decision to stop using the product immediately," a ministry official said.

The recent decision drove Medytox into a corner where it could lose regulatory approval for its three BTX products -– Meditoxin, Coretox, and Innotox -- in Korea, industry watchers said.

The regulator revoked the permit for Meditoxin and Coretox after confirming that the company had violated the Pharmaceutical Affairs Act by selling export products in the local market.

In response to the regulator's decision, a Medytox official said, "We will immediately file a complaint against the decision and take administrative procedures to halt the execution."

Meanwhile, Medytox and Daewoong Pharmaceutical remain locked in a dispute since 2016, as the former filed a suit alleging that the latter stole BTX strain to turn the deadly toxin into wrinkle treatment.

The U.S. International Trade Commission has recently given a final ruling that favored Medytox, but civil and criminal lawsuits are still going on in Korea.

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