The FDA has deemed phenylephrine ineffective as an oral decongestant, prompting South Korea's MFDS to review related cold medicines.

COMPANY / Reporter Kim Jisun / 2024-11-18 07:39:08

 

 

[Alpha Biz= Reporter Kim Jisun] The U.S. Food and Drug Administration (FDA) has provisionally concluded that phenylephrine, an active ingredient in many oral decongestants, is ineffective. In response, South Korea's Ministry of Food and Drug Safety (MFDS) has initiated a comprehensive review of cold medicines containing the ingredient.

According to industry reports on the 17th, the FDA has issued a proposed order to remove phenylephrine from the list of over-the-counter (OTC) oral decongestant ingredients. While phenylephrine is known to alleviate nasal congestion, the FDA found that oral administration does not deliver sufficient quantities to produce the desired effect. After a six-month public consultation period, the FDA will decide whether to discontinue the sale of medications containing phenylephrine.

The MFDS is now reviewing the efficacy of phenylephrine in domestic cold medicines, including Dongwha Pharm's Pancol-A, Kolon Pharmaceutical's Comy Syrup, and Daewoo Pharm's Coben Syrup. 


The results of these reviews could influence the availability of popular cold medications in the domestic market.

 

 

Alphabiz Reporter Kim Jisun(stockmk2020@alphabiz.co.kr)

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