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Home » Hospira Sues FDA Over Generic Precedex ‘Carve-Out’ Approval
Hospira Sues FDA Over Generic Precedex ‘Carve-Out’ Approval
Hospira has won a temporary restraining order blocking Mylan from marketing a generic version of its sedative Precedex, which the FDA authorized last week under the controversial section viii statement pathway that foregoes a patent challenge and instead allows manufacturers to “carve out” indications not protected by patents.