FDA’s newly released draft bioequivalence guidance outlining recommendations for generic manufacturers looking to market copies of GlaxoSmithKline PLC’s bestselling Advair Diskus (fluticasone/salmeterol) sets high hurdles that will likely only be able to be met by a limited number of ANDA hopefuls, Mylan NV President Rajiv Malik said.
While few generic players may not be comforting to GSK, which stands to lose a substantial chunk of its sales – Advair is the number two biggest drug in the world and accounts for about 18% of the company’s total sales – the
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