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  • MFDS starts review on phenylephrine after FDA advisory decis
  • by Lee, Hye-Kyung | translator Kim, Jung-Ju | Sep 19, 2023 05:42am
FDA¡¯s NDAC deems the ingredient ¡®not effective¡¯
Plans to proceed with expert discussions based on domestic use experience
 ¡ã Syrup formulation of phenylephrine that is being used as a cold medicine

With the Nonprescription Drug Advisory Committee (NDAC) concluding that the nasal decongestant ¡®phenylephrine¡¯ is not effective, Korea¡¯s Ministry of Food and Drug Safety is also preparing to conduct its review.

An MFDS official said, ¡°We will decide on future measures after a comprehensive review, including discussion with experts, based on data on domestic use experience of medicines that contain the relevant ingredient. We do not know what sanctions the FDA will announce in the future, whether it will be banned or used, but we plan to conduct our review at the Ministry of Food and Drug Safety level.¡±

The controversy over the effectiveness of phenylephrine arose after the results of the FDA¡¯s advisory
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