Medytox seeking to cancel gov't sales ban

Medytox Korea in Seoul / Courtesy of Medytox

By Jun Ji-hye

Medytox, the nation's leading botulinum toxin maker, has filed a lawsuit, asking a court to cancel the Ministry of Food and Drug Safety's orders that the company suspend the manufacture, sale and use of three dosage units of Meditoxin, the company said Monday.

The company claimed, “There have been no reports to date of any severe adverse effects for those using Meditoxin, of which 1,690 vials (100 unit equivalent) were manufactured,” between its launch in 2006 to last year.

The firm's request submitted to Daejeon District Court, Sunday, came after the ministry had suspended the manufacture, sale and use of 50-unit, 100-unit and 150-unit Meditoxin products, Friday.

Meditoxin botulinum toxin products developed by Medytox / Courtesy of Medytox

The ministry has also begun the process of canceling the firm's license to sell the product.

The decision was made after the prosecution disclosed the results of its investigation that Medytox had allegedly used an unapproved ingredient to produce the drug and acquired export approval by fabricating efficacy test results.

The investigation 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.

Medytox claimed the Meditoxin products in question were manufactured from December 2012 to June 2015, and were all used up a long time ago.

“Therefore, no harm to public health can currently exist. The Meditoxin products that are currently being distributed were manufactured after April 2017,” the firm said.

It added that there have been no issues during the ministry's numerous inspections into the efficacy and safety of the products.

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

The product, along with the venture biotech company's new botulinum toxin type A products, INNOTOX and Coretox, are sold in about 60 countries around the world, according to the company.