The Ministry of Food and Drug Safety said Tuesday it has canceled the drug approval for antidepressant Valdoxan 25mg (ingredient: agomelatine), as its manufacturer Servier Korea failed to submit applications for a re-evaluation of the drug for twice.
According to local safety regulations on pharmaceutical products, the government can nullify drug approval if the drugmaker does not submit a re-evaluation request form within three months after the termination of the re-evaluation period, or fail to submit all of the documents necessary for re-evaluation.
One-time failure to apply will lead to a six-month suspension of sales. Two-times failure leads to cancellation of the drug approval.
The Korean unit of French drugmaker Servier did not submit a re-evaluation request form in April and faced a six-month sales suspension. The firm failed to do so this time and finally had its drug approval canceled.
Valdoxan is an antidepressant, working as a melatonin agonist and 5-HT2C serotonin antagonist to approve sleep quality. Physicians prescribe the drug for sleep disorder accompanied by depression. The drug causes fewer side effects regarding sexual dysfunction, sleep disorder, weight gain, and discontinuation effects.
In 2015, Servier Korea tried to push Valdoxan to be covered by the national health insurance but failed. At the time, the Health Insurance Review & Assessment Service (HIRA) refused to cover the drug with the state insurance, saying “depression is not a rare disease of minority and it can be treated with many drugs that have been already approved.” Considering that there were many alternatives, Valdoxan was not a drug that should be mandatorily prescribed after a physician’s examination, the HIRA said.
After the HIRA’s decision on Valdoxan, Servier Korea supplied the drug on request by registering the product code but did not carry out aggressive sales and marketing. With local drugmakers such as Hyundai Pharmaceutical and Korea Pharma developing generic drugs, Servier Korea intentionally faced the cancellation of the drug approval to cease the domestic sales, some observers said.
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