GSK Ariflo Long-Term Efficacy Trials Needed For COPD Approval – FDA Cmte.
Executive Summary
GlaxoSmithKline's Ariflo needs long-term efficacy studies to confirm the PDE-4 inhibitor's maintenance of effect in chronic obstructive pulmonary disease, an FDA advisory committee agreed Sept. 5
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GlaxoSmithKline's pending chronic obstructive pulmonary disease therapy Ariflo (cilomilast) is among a dozen products manufactured in Cidra, Puerto Rico cited in recent FDA "Form 483" reports