South Korea's drug authorities on Wednesday revoked its permit for the gene therapy drug Invossa for mislabeling and the false reporting of an ingredient used.
The Ministry of Food and Drug Safety said it made the final decision banning the production and sales of Invossa after it canceled the license for the drug made by Kolon Life Science in late May and ordered the suspension of sales in April. The ban officially goes into effect next Tuesday.
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(Yonhap) |
Kolon Life acknowledged that a substance in the joint pain treatment drug has been mislabeled since 2003, with authorities arguing the company intentionally did not disclose additional data it discovered on the problem before submitting the drug for approval. State regulators added the drugmaker failed to provide a scientific cause for the mix-up.
A material used in Invossa, which was approved for sale in 2017, came from a kidney cell instead of from cartilage as stated in the document submitted for approval, according to the ministry.
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(Kolon Life Science) |
At present, there have been no cases of side effects associated with Invossa, but all people who have received treatment will be closely monitored for upwards of 15 years.
A total of 438 hospitals and clinics have administered 3,707 shots of the drug so far. (Yonhap)
