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Hyundai withdraws application for Mifegymiso approval again

By Lee, Hye-Kyung | translator Alice Kang

24.11.01 05:51:47

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MFDS ¡°Relevant laws must be set first for review and approval¡±

Hyundai Pharm applied for the drug¡¯s approval twice in 2021 and 2023, both of which were discontinued



Hyundai Pharm has reportedly voluntarily withdrawn the application it had filed for the marketing authorization of Mifegymiso (mifepristone and misoprostol), which the company had applied for approval as the first abortion pill in Korea.

Hyundai Pharm has requested approval for the abortion drug twice in the past, first in 2021 and then in 2023, but the Ministry of Food and Drug Safety has repeatedly asked for supplemental data, due to which the company has not been able to receive proper review.

According to the MFDS¡¯s written response to a written inquiry made during the NA Audit by the Health and Welfare Committee on the 31st, the approval and review process for Mifegymiso wa

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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