53 Hepsera generics waiting for regulatory approval

A total of 53 domestic drug makers are waiting for the green light of the Korea Food and Drug Administration to launch their generics for GlaxoSmithKline’s Hepsera (adefovir dipivoxil) as the re-examination period of the original brand was already expired on February 18.

Of the 53 generic products in file, the drug agency said that some validation documents for 30 products should be suppleme...