Eyes on approval of ‘acetaminophen+ ibuprofen’ combo OTCs
By Lee, Tak-Sun | translator Alice Kang
21.05.13 12:20:56
가나다라
0
First approved as OTC by the U.S FDA last year… has better effect than as monotherapy
OTC approval of the combo was turned down in 2017 in Korea… due to concerns on abusing and safety
MFDS to discuss approval at the Pharmaceutical Affairs Council meeting on the 17th
▲미국에서 OTC로 발매된 최초의 아세트아미노펜+이부프로펜 복합제 <애드빌 듀얼 액션>
The Ministry of Food and Drug Safety (MFDS) is reviewing the approval of an acetaminophen and ibuprofen combination therapy as an over-the-counter drug (OTC). The two ingredients are well-known antipyretic-analgesics, however, the combination of only these two ingredients was not commonly used as the two have different mechanisms of actions. However, with the U.S Food and Drug Administration (FDA) approving the first acetaminophen and ibuprofen combination drug as an OTC, the possibility of seeing the combination in Korea is also rising.
According to the MFDS on the 13th, the members of the Central Pharmaceutical Affairs Council will be discussing whether to classify the acetaminophen
Lee, Tak-Sun(hooggasi2@dailypharm.com)
If you want to see the full article, please JOIN US (click)