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Regulatory Focus™ > News Articles > China: SFDA Amends OTC Manual for Amantadine Hydrochloride Compounds

China: SFDA Amends OTC Manual for Amantadine Hydrochloride Compounds

Posted 17 May 2012 | By Louise Zornoza

The Chinese State Food and Drug Administration (SFDA) issued a Notice to Provinces, Autonomous Regions, and Municipalities on 16 May revising the instructions in the Chinese non-prescription drugs (OTC) manual related to the pediatric use requirements for amantadine hydrochloride compounds. 

The compounds can no longer be used in newborns and children under one year of age due to a lack of safety and effectiveness data and are not recommended for children under the age of five. Drug manufacturers must amend labeling accordingly and local authorities must ensure timely reporting of adverse reactions.

Read more:

SFDA - State Food and Drug Administration to amend the non-prescription drug instructions containing amantadine hydrochloride

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