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FDA’s New Category For Pre-1984 ANDAs May Impact Patent Exclusivity, Product Liability

Executive Summary

The agency aims to treat ANDAs approved prior to enactment of the Hatch-Waxman amendments, dubbed PANDAs, as 505(b) NDAs. The goal is to make it easier to designate products as reference listed drugs, but experts say it effectively turns ANDA holders into NDA holders, which could have implications for label changes, patent listings, and product liability litigation.

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