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Drugmaker Mylan’s shares fell in afternoon trading after it said US regulators had rejected its application to market a generic version of Advair, GlaxoSmithKline’s blockbuster asthma drug.
Mylan said that the US Food and Drug Administration had issued a complete response letter — meaning, that the application review was complete and that it would not be approved in is present form — on its submission regarding a generic version of Advair.
“Mylan is in the process of reviewing this response and will provide an update on its application as soon as practicable once it has completed its review and discussed the FDA’s feedback with the agency,” the company said in a statement.
It shares were down more than 3 per cent ahead of Tuesday’s close.