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  • Cushing¡¯s syndrome drug Isturisa is approved in Korea
  • by Lee, Hye-Kyung | translator Alice Kang | Sep 20, 2024 05:51am
Gov¡¯t reviews various dosage forms
MFDS completes safety and efficacy review of 1mg and 5mg doses
Various doses of ¡®Isturisa¡¯ (osilodrostat), a treatment for Cushing's syndrome, are expected to be approved in Korea soon.

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, and 10 mg – the MFDS has compl
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