The government said it would change approval conditions for two pharmaceutical products that use amantadine sulfate as the main ingredient, due to lack of evidence in drug safety and efficacy.

The decision follows the government’s review of safety and efficacy every five years whether to extend the approval conditions.

The Ministry of Food and Drug Safety said on Friday that it would delete amantadine sulfate’s indication for “the prevention and treatment of respiratory infections by influenza A virus,” in two medicines – Hanwha Pharma’s P.K.-Merz Tab. and Korean Drug’s Amanta Tab.

The ministry said that additional data of safety and efficacy, submitted to the ministry for renewal of drug approval, did not have sufficient evidence to maintain the indication.

The approval condition for P.K.-Merz Infusion Inj., the medicine using the same ingredient imported by Hanwha, does not include the indication for the influenza A treatment.

The ministry plans to collect opinions about the decision to delete the indication by Oct. 22 and order the two drug companies to notify the changes in the approval condition.

lhs@docdocdoc.co.kr

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