FDA denies GSK's higher-strength Advair Diskus for COPD

08/8/2007 | Bloomberg · Wall Street Journal, The

GlaxoSmithKline received an nonapprovable letter from the FDA for a higher-strength version of its inhaled Advair Diskus for chronic obstructive pulmonary disease. The rejection was made despite an advisory panel's earlier recommendation for its approval, catching the company by surprise, said a vice president. The executive noted the panel's unanimous vote and studies showing success in treating the disease. GSK said it would meet with the FDA to discuss ways to get the higher strength approved.

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Bloomberg · Wall Street Journal, The

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