Perrigo "Drug Facts" Deferral Requests Include Products With Templates
This article was originally published in The Tan Sheet
Executive Summary
Perrigo has requested a deferral from the OTC labeling final rule's effective date for several drugs that FDA already has provided template "Drug Facts" labels.
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Generic drugs approved under ANDAs may conform to "Drug Facts" labeling as it appears in templates posted on FDA's Web site without having to wait for the reference listed drug's labeling to be approved.
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Generic drugs approved under ANDAs may conform to "Drug Facts" labeling as it appears in templates posted on FDA's Web site without having to wait for the reference listed drug's labeling to be approved.