Nexstar DaunoXome corrective promotion letter requested in FDA warning letter to company.
Executive Summary
NEXSTAR DAUNOXOME CORRECTIVE LETTER REQUESTED BY FDA in response to concerns outlined in a Feb. 21 warning letter over the company's promotion of DaunoXome (daunorubicin citrate liposome injection). "Nexstar should propose a corrective action plan, including the mailing and publication of a `Dear Healthcare Provider' letter to correct the false and/or misleading messages" cited by FDA, the warning letter states.