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  • Felodipine indication to get limited to stable angina
  • by Lee, Tak-Sun | translator Byun Kyung A | May 8, 2020 06:34am
MFDS orders change in angina related indication, to be applied on 33 items including Handok¡¯s Munobal
 ¡ã Original felodipine ¡®Munobal¡¯ by Handok
Felodipine, used on patients with hypertension and angina, is facing an indication adjustment to only treat stable angina when used for angina.

Korea Ministry of Food and Drug Safety (MFDS) is planning to finalize the order to change the medicine¡¯s indication on May 22. A calcium channel blocker (CCB), felodipine has a brand-name drug like Munobal tablet (Handok), approved in 1990.

After reviewing safety and efficacy data submitted for the oral felodipine¡¯s license renewal, MFDS announced it has decided to alter the drug¡¯s indication. The final order would be made on May 22 as the ministry has previously issued the preannouncement.

Initially labeled as hypertension and angina treatment, the drug would b
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