Medytox to file suit to reverse gov't revoking of license

Meditoxin botulinum toxin products developed by Medytox / Courtesy of Medytox

By Jun Ji-hye

Medytox plans to file a lawsuit to ask a court to reverse the drug safety watchdog's decision to revoke the botulinum toxin maker's license to sell its products, company officials said Thursday.

“We will cope with the situation by applying for a provisional injunction and filing a lawsuit to nullify the decision,” a Medytox official said.

The comments came hours after the Ministry of Food and Drug Safety announced that the permit of the company's 50-unit, 100-unit and 150-unit Meditoxin products will be revoked and permanently removed from domestic shelves, starting from June 25.

The ministry said the pharmaceutical company was found to have used an unapproved ingredient to produce the drug and fabricated efficacy test results between 2012 and 2015 to obtain the license to manufacture and sell the products.

The ministry noted such acts were in violation of pharmaceutical laws.

“A company that fabricates documents and distributes inappropriate products cannot be trusted,” a ministry official said. “Such acts can exert a huge influence on the health of the public, and can also harm the domestic pharmaceutical industry's reputation in the global market.”

The official added, however, that the ministry reached the conclusion that Meditoxin products do not pose significant safety risks.

Launched in 2006, Meditoxin became the first botulinum toxin product made in Korea and the fourth in the world.

The investigation by the prosecution and the ministry was initiated following a report made last year by a former Medytox employee to the Anti-Corruption and Civil Rights Commission. The employee was working for the firm's smaller rival, Daewoong Pharmaceutical, at the time.

The ministry already issued an administrative order, April 17, to suspend the manufacture and sale of three dosage units of Meditoxin.

At the time, Medytox filed a lawsuit, asking the Daejeon District Court to suspend the order.

According to industry officials familiar with the issue, the Daejeon court suspended the administrative order in May as requested by the company.

“Given that the ministry has acknowledged that Meditoxin does not pose significant safety risks, there is great possibility for a court to rule in favor of Medytox this time too,” the official said.