FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

New Zealand Calls for Feedback on Labeling Warnings for Allergens

July 12, 2019
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New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) issued suggested labeling for substances in drugs that could cause allergic reactions.

The agency is seeking feedback on a list of substances to be included in its label statement database, which details required warning and advisory statements for drug labels. It proposes to list antibiotics, sodium salts, benzoates, phenylalanine, hydroxybenzoic acid esters and galactose, among other items.

“Some potential allergens, such as impurities from manufacturing, may not be on the label,” Medsafe said, noting that most drugs do not have to list all their ingredients on their labels.

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