OTC Labeling Final Rule Extension For ANDA Holders Requested By Perrigo
This article was originally published in The Tan Sheet
Executive Summary
FDA's draft guidance stating ANDA holders need not wait for OTC reference listed drug makers to implement "Drug Facts" labeling before they use such labeling would create an "unexpected hardship" on private labelers, Perrigo maintains in comments to the agency.
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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.