KFDA Delays Decision on Hanmi’s Anti-Obesity Drug with Novel Salt Formulation

The delayed decision by the Korea Food and Drug Administration (KFDA) on an approval of Hanmi Pharmaceutical’s anti-obesity drug Slimer is triggering debates on the current regulatory process that governs the approval of new chemical drugs with novel salt formulation during the re-examination period.

According to Hanmi, the KFDA communicated of a decision on February 17th to postpone its app...