Medytox may lose license to sell botulinum toxin: Ministry

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Medytox may lose license to sell botulinum toxin: Ministry

The government has pulled Medytox’s main botulinum toxin product off the shelves for using an unapproved ingredient in the manufacturing process and may void its license to sell the toxin, the Ministry of Food and Drug Safety announced Friday.

The Korea drug authority announced in a statement it is indefinitely suspending the production, sale and use of three dosage types of Meditoxin. The ministry is also planning to impose a three-month manufacturing ban on Medytox for the alleged violation while it begins the process to cancel the product’s license.

Botulism toxins, best known under Allergan’s Botox drug, is a widely used toxic substance that paralyzes muscles to reduce wrinkles.

Launched domestically in 2006, Meditoxin was the first approved botulinum toxin product in Korea and is reportedly sold in 60 countries at the moment.

According to Medytox’s annual report for last year, botulinum toxin and filler accounted for 93.1 percent of the company’s 205.9 billion won ($169 million) in sales revenue.

Although the company does not reveal any further details of its sales proportions, Hana Investment & Securities estimated in a report that botulinum toxin products accounted for 56.4 percent of total revenue for the company.

Earlier on Friday, the prosecution filed a criminal complaint against Medytox CEO Jung Hyun-ho without arrest in the case.

The ministry believes the company manufactured Meditoxin with an ingredient that was not previously disclosed and approved by the authority.

The drug approval authority said it has been cooperating with the prosecution’s investigation after the ministry asked law enforcement to follow up on a whistleblower complaint that accused Medytox of fabricating efficacy test results on Meditoxin.

Since last year, Medytox has been accused of acquiring export approval for some of its products by intentionally misreporting data on ingredients and efficacy.

The company and its top executives have been under investigation for possibly fabricating efficacy and safety test results and unfairly winning dozens of export approvals for its botulinum toxin products.

Yet the ministry also said it is unlikely that the measure will negatively impact consumer interest, as the amount of botulinum toxin usually injected to patients are too low to create any lasting adverse effect. The ministry said it will work with outside counsel to determine whether to take any additional action against the company.

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