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  • Whanin, begins development of first generic for Fycompa
  • by Lee, Tak-Sun | translator Choi HeeYoung | May 13, 2020 05:54am
3 years remaining until the expiration of the product patent
 ¡ã Antiepileptic drug Fycompa by Eisai
Whanin, for the first time as a domestic pharmaceutical company, started developing generics for antiepileptic drug Fycompa by Eisai. If the generic development proceeds smoothly, it is expected that it will be aprproved next year as soon as possible.

The MFDS approved the bioequivalence test plan for 'Peranel 6mg' submitted by Whanin on the 8th. Peranel is an imaginary item that has not yet been approved, and is the same ingredient as Fycompa.

The bioequivalence test is conducted for the purpose of securing equivalence by comparing the absorption rates of Peranel and Fycompa in 56 healthy adults. The test was designed to run through May next year.

Anyway, application for permission is possible only in July o
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