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Will approval of brain function enhancers be revoked?

By Lee, Hye-Kyung | translator Alice Kang

22.08.09 17:17:05

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MFDS discloses reevaluation result¡æcompanies submit objections¡æfinal action... one month left to final action

Director Kyung Seung Shin, ¡°If the companies' objections are not accepted, the drug will be subject to recall and sales suspension dispositions"

Whether acetyl-L-carnitine, which failed to verify its efficacy in its ¡®secondary degenerative diseases caused by cerebrovascular disease¡¯ indication during clinical reevaluations, will be able to maintain its marketing authorization status will be determined within September this year.

The Ministry of Food and Drug Safety issued a Dear Healthcare Professional Letter on the 5th recommending the use of alternative drugs and discontinuing the prescription and dispensing of drugs that contain acetyl-L-carnitine.

At the MFDS correspondents¡¯ briefing held on the 9th, Kyung Seung Shin, Director of the Pharmaceutical Safety Evaluation Division at MFDS, said, ¡°We have disclosed the reevaluation

Lee, Hye-Kyung(hgrace7@dailypharm.com)
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