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  • 2nd GIFT drug Nefecon¡¯s approval imminent in Korea
  • by Lee, Hye-Kyung | translator Alice Kang | Oct 21, 2024 05:48am
a drug that developed a new indication with a marketed ingredient
MFDS designated the drug the 2ndGIFT drug¡¦a treatment for IgA nephropathy 
Meditip's Nefecon (budesonide), which was designated as the 2nd Global Innovative Products on Fast Track (GIFT) drug last year, is close to receiving approval in Korea.

According to industry sources on the 21st, the Ministry of Food and Drug Safety recently completed the safety and efficacy review for Nefecon. The completion of the safety and efficacy review in general leads to approval in Korea.

Nefecon has been designated as a GIFT item as a drug that developed a new efficacy and effectiveness using the already marketed budesonide ingredient.

A GIFT designation can also be given to a previously approved ingredient that has no treatment for a disease but can be used to treat a new patient population.

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