Seroquel Generics Suit Is AstraZeneca’s Bid To Control Diabetes Safety Data
FDA nearly always prevails in lawsuits that challenge generic approvals, but AstraZeneca’s argument is relatively fresh and could be bolstered by the agency’s decision to deny the firm’s citizen petition without comment.
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Updated drug pricing bill would allow US FDA to approve generics even if innovator safety information is protected by exclusivity.
Pharma industry critics herald the agreement for allowing many manufacturers around the world to make the COVID-19 therapeutic and for its transparency. If Merck can do it, they ask, why can’t other companies?
Federal Circuit ruling in GSK v. Teva shows brands can broaden a use code to include other patented indications years into litigation, AAM attorney says. The case is ‘scarier’ for biosimilar makers since they must market their products, Teva lawyer notes.