Drug gi­ant As­traZeneca was de­nied ap­proval of a di­a­betes drug com­bi­na­tion treat­ment by the Food and Drug Ad­min­is­tra­tion, which is re­quest­ing more clin­i­cal data on pre­vi­ously ap­proved ther­a­pies saxagliptin and da­pagliflozin, known by their brand names as O

Modern Healthcare - - LATE NEWS -

As­traZeneca stated that the data re­quested in­cluded in­for­ma­tion from “on­go­ing and com­pleted stud­ies and may re­quire in­for­ma­tion from new stud­ies.” As­traZeneca has spec­u­lated an­nual sales of up to $3 bil­lion from its com­bi­na­tion prod­uct. A de­lay in its ap­proval could set the com­pany back in its ef­forts to grab a size­able share of a mar­ket that, with the in­tro­duc­tion of sev­eral block­buster drugs, has be­come in­creas­ingly com­pet­i­tive in re­cent years.

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