GSK says FDA declines to approve higher dose Advair

NEW YORK, Aug 8 (Reuters) - GlaxoSmithKline Plc. (GSK.L: Quote, Profile, Research, Stock Buzz) said on Wednesday that U.S. health regulators declined to approve a higher strength version of its inhaled Advair Diskus for the treatment of chronic obstructive pulmonary disease (COPD).

Europe's largest drugmaker said it received a non-approvable letter from the Food and Drug Administration for the 500/50 strength version of the medicine even after an advisory panel had unanimously recommended approval. The 250/50 Advair Diskus was approved in 2003 for maintenance treatment of airflow obstruction in COPD patients.

The FDA questioned how Advair 500/50 compared to the currently approved 250/50 strength in order to allow for appropriate dosing recommendations, Glaxo said. (Reporting by Bill Berkrot)