FDA’s Policy On “Authorized” Generics Upheld By Appeals Court

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.