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Home » GSK, Amgen Can Drop REMS for Bone Marrow Stimulators
GSK, Amgen Can Drop REMS for Bone Marrow Stimulators
December 9, 2011
Two blood-platelet stimulators, GlaxoSmithKline’s (GSK) Promacta and Amgen’s Nplate, still pose risks, but FDA-imposed safety monitoring programs and other restrictions are no longer necessary to ensure the products’ benefits outweigh their risks, the agency said Tuesday.