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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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Teva says it is evaluating the potential market withdrawal of many products approved prior to enactment of the Hatch-Waxman Act in response to an FDA proposal to treat them as new drug applications. AAM notes that many of these so-called PANDA drugs are on the agency’s drug shortage list.

Generic Firms Likely To Withdraw Drugs If US FDA’s Pursues ‘Disastrous’ PANDA Policy

Teva says it is evaluating the potential market withdrawal of many products approved prior to enactment of the Hatch-Waxman Act in response to an FDA proposal to treat them as new drug applications. AAM notes that many of these so-called PANDA drugs are on the agency’s drug shortage list.

US FDA’s PANDA Policy Could Pose Legal Problems For Biosimilars, Attorney Says

Agency’s apparent ‘intellectual exercise’ in treating pre-Hatch-Waxman ANDAs as NDAs could expose biosimilars to liability, Teva deputy general counsel notes at FDLI conference.

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