GSK’s Avandaryl Approved, But Manufacturing Changes Are Still Pending
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
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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
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
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