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Teva Legal Challenge Against "Authorized" Generics Rejected By D.C. Court

This article was originally published in The Pink Sheet Daily

Executive Summary

Any reduction in the economic value of an ANDA first-filer's product during the 180-day exclusivity period "does not rise to the level of absurdity" requiring the court to look beyond the "plain language" of the FD&C Act, D.C. Judge Walton rules. Teva is appealing the decision.

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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.

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.

Congress, Not Court, Is Place To Change "Authorized" Generic Policy, Judge Says

Congress is a better venue for changing FDA's regulation of "authorized" or brand generics, a D.C. Circuit Court of Appeals judge suggests. Teva faces skepticism during oral arguments in its challenge of the agency's refusal to block authorized generics during an ANDA first-filer's 180-day exclusivity.

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