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  • Chong Kun Dang generic to open Atozet generic market
  • by Lee, Tak-Sun | translator Byun Kyung A | Jul 21, 2020 06:10am
The Korean company applies for approval on CKD-391 in April with individually conducted clinical trial data
Only after January when the original PMS expires, other competing generics can apply for approval
Chong Kun Dang already acquired accounts for the generic through original co-marketing deal
 ¡ã MSD Korea
As Atozet¡¯s post-marketing surveillance (PMS) expiration is approaching in next year, Chong Kun Dang is closely eyeing on the follow-on drug market.

While many of Atozet (atorvastatin plus ezetimibe) generic makers are currently developing evidences like bioequivalence test to seek approval after Jan. 22 next year when the original¡¯s PMS period ends, Chong Kun Dang has already submitted an approval application to the Korean health authority by providing data from individually conducted clinical trial.

According to the pharmaceutical industry sources on July 17, Chong Kun Dang has completed clinical trial and requested Ministry of Food and Drug Safety (MFDS) in last April to approve an atorvastatin plus ezet
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