First Depakote generic is being reviewed for reimb in KOR
By Lee, Tak-Sun | translator Kim, Jung-Ju
23.12.07 05:50:42
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HIRA starts insurance price calculations¡¦ will likely be listed in Feb next year
The drug is ¡®Divalpro ER Tab 500mg,¡¯ developed by Korea Pharma. The drug was first approved in Korea on November 8th. It is the first generic drug to contain divalproex sodium, the main active ingredient of Depakote ER.
Depakote ER was approved in Korea in 2002. It was approved in two dosage forms, and the drug posted sales of KRW 10 billion in 2022 according to IQVIA.
With no patents listed on the MFDS¡¯s green list, there were no obstacles to the approval or release of its generic versions. However, due to difficulties in bioequivalence testing, only a
Lee, Tak-Sun(hooggasi2@dailypharm.com)
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