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

Executive Summary

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.

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