GSK’s Avandaryl Approved, But Manufacturing Changes Are Still Pending
Executive Summary
GlaxoSmithKline's diabetes line extension product Avandaryl has cleared FDA, but the firm plans to move manufacturing for commercial supply of the drug out of its problematic Puerto Rico plant
You may also be interested in...
Avandaryl Approval On Track Despite Consent Decree, GSK Says
GlaxoSmithKline is confident FDA will approve its diabetes line extension agent Avandaryl on schedule despite the fact that the manufacturing facility for the product is operating under a GMP consent decree
GSK Signs GMP Consent Decree For Cidra Plant But Avoids Disgorgement Fee
Good manufacturing practices compliance efforts under GlaxoSmithKline's consent decree with FDA are likely to cost the company significantly less than Schering-Plough's 2002 agreement with the agency
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011