US argues that AstraZeneca's IRA suit 'fares no better than the others'
The Department of Justice on Wednesday took a crack at dismantling AstraZeneca’s lawsuit over the selection of its type 2 diabetes drug Farxiga (dapagliflozin) for drug price negotiations, saying it “fares no better than the others.”
AstraZeneca, which filed its complaint in Delaware federal court in August, contested two aspects of CMS’ guidance explaining how it planned to select which drugs would be included in the first year of negotiations. The British company took issue with the way that CMS defines “qualifying single source drug,” with the drugmaker saying it should encompass “only one NDA or BLA.” It also took issue with the way CMS defined competition, saying generics don’t need to be marketed in a “bona fide” manner.
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