Cushing¡¯s syndrome drug Isturisa is approved in Korea
By Lee, Hye-Kyung | translator Alice Kang
24.09.20 05:12:54
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MFDS completes safety and efficacy review of 1mg and 5mg doses
According to industry sources on the 19th, the Ministry of Food and Drug Safety concluded the safety and efficacy review of Recordati Korea's Isturisa Film Coated Tab 1mg earlier this month and recently completed the safety and efficacy review of the 5mg dose as well.
Isturisa was previously approved by the US Food and Drug Administration (FDA) on March 6, 2020, the European Medicines Agency (EMA) on January 9, 2020, and Japan¡¯s Pharmaceuticals and Medical Devices Agency (PMDA) on March 23, 2021.
Among the three dosage forms available – 1, 5,
Lee, Hye-Kyung(hgrace7@dailypharm.com)
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