FDA’s Policy On “Authorized” Generics Upheld By Appeals Court
This article was originally published in The Pink Sheet Daily
Executive Summary
Waxman/Hatch provisions barring FDA from approving a later-filed ANDA do not prevent the marketing of generics under an innovator’s NDA during the 180-day exclusive period, the D.C. Circuit Court of Appeals says. The court also rejects Teva’s arguments that FDA should regulate “authorized” generics through supplemental NDAs.
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