OTC combination drug with APAP-IBU, not approved again

Last year, it applied for FDA-based approval, but the Central Pharmaceutical Affairs Review Committee refused

7 out of 10 members opposed because the safety issue was not resolved

Advil Dual Action in US

OTC approval of APAP-IBU complex has failed again.

 

Experts who participated in the review objected to the permission on the grounds that safety issues had not been resolved.

 

According to the Central Pharmaceutical Affairs Review Committee minutes released on the 7th, seven out of 10 members opposed the OTC approval of Acetaminophen-Ibuprofen.

 

The MFDS is also known to have opposed it, and finally, the complex failed to make its second attempt at licensing after 2017.

 

Based on UK permit in 2017, this time it applied for permit based on US FDA.

 

The complex requested in 2017 was a product that take one or two tablets of Acetaminophen 500mg-Ibuprofen, and it applied for permission to take two tablets of Acetaminophen 250mg-Ibuprofen 125mg.

 

The U.S.

 

FDA approved GSK's "Advil Dual Action" containing Acetaminophen 250 mg and Ibuprofen 125 mg as OTC.

 

It was the first case in the United States that Acetaminophen-Ibuprofen complex was approved as OTC.

 

At the Central Pharmaceutical Affairs Review Committee held on the 17th of last month, members of outside experts generally opposed.

 

"There are already many single drugs, but the benefits of taking them as a complex seem to be in marketing rather than validity," a member said.

 

"It is questionable whether consumers will keep the fact that they should take them within three days because they are feared to have side effects in the long term." Another member of the committee opposed, "We reviewed it as complex of the same ingredients in 2017, and it seems that there is no special accumulation of data on safety or efficacy of drugs.

 

Clinically, elderly patients experience a lot of gastrointestinal bleeding after taking a lot of painkillers." Another committee member said, "I think it is important to the general consumer that the risk is greater than the benefit.

 

Failure to comply with dosage can increase the risk of liver damage, and it is not appropriate to grant permission." A member of the Committee in favour of permitting the complex stressed that it was appropriate in terms of accessibility.

 

"There are consumers who want to buy items that are very popular in the U.S.

 

but are currently illegally using them in Korea.

 

Pediatrics often use both for fever at the same time, and they already prescribe Acetaminophen as powder and Dexibuprofen as liquid." However, only three out of 10 members voted in favor of the permit, and the deliberation committee voted that the approval of OTC for Acetaminophen-Ibuprofen was not valid.

 

Based on this, the MFDS also reportedly refused to grant permission.

 

Kolmar's "Bufferin Lady," which was approved in 2008, also contains Acetaminophen (65 mg) and Ibuprofen (65 mg).

 

However, it also includes Allylisopropylacetylurea and Caffeine Anhydrous.