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  • Atozet latecomer CKD Atoezy wins approval without PMS
  • by Lee, Tak-Sun | translator Byun Kyung A | Oct 17, 2020 06:36am
RMP to replace post-marketing use-result surveillance, accurate release date unknown
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Chong Kun Dang has reportedly received the South Korean health authority¡¯s approval on a follow-on drug of MSD¡¯s dyslipidemia treatment Atozet.

The approval preceded Atozet¡¯s post-marketing surveillance (PMS) end date on Jan. 22 next year by three months, putting the latecomer on an advantageous position.

However, the estimated launch date is still unknown as the South Korean company is to call for a CMO to manufacture the same substance drug.

Chong Kun Dang¡¯s Atoezy is not pressured to meet the PMS conditions as Atozet¡¯s outstanding PMS period did not carry over.

On Oct. 13, the Ministry of Food and Drug Safety (MFDS) green lit three doses of Atoezy by Chong Kun Dang. The drug shares the same s
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