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Will the 37th new drug in Korea receive approval?

By Lee, Hye-Kyung | translator Kim, Jung-Ju

24.04.21 16:40:16

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The Ministry of Food and Drug Safety (MFDS) has completed the safety and efficacy assessment of the active ingredient, 'zastaprazan'


 ¡ãJeil Pharmaceutical.


The approval for the 37th new drug in Korea is approaching.

According to industry sources on the 22th, the Ministry of Food and Drug Safety (MFDS) completed the safety and efficacy assessment of the three zastaprazan-containing products from Onconic Therapeutic, Jeil Healthscience, and Jeil Pharmaceutical.

The completion of the safety and efficacy assessments by MFDS indicates that approval is nearing.

Jeil Pharmaceutical simultaneously applied for new drug approvals from three affiliated companies, including Jeil Healthscience, which manufactures over-the-counter drugs, and its subsidiary, Onconic Therapeutic, which specializes in new drug R&D.

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