Teva Takes FDA To Court In Challenge To “Authorized” Generics
This article was originally published in The Pink Sheet Daily
Executive Summary
The generic firm sues FDA, asserting the agency exceeded its expertise in finding that the marketing of “brand generics” during a first-filer’s 180-day exclusivity period promotes competition. Teva’s lawsuit in D.C. federal court comes two weeks after Mylan filed a separate, but similar, action against FDA in West Virginia.
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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.
Teva Legal Challenge Against "Authorized" Generics Rejected By D.C. Court
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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