Pfizer's Exubera: Breathing New Life Into Inhaled Insulin

Dragging a host of safety concerns, Exubera hardly inspired confidence when it went before an FDA advisory committee. But Pfizer proposed an aggressive risk management scheme that won it a dramatic "yes" vote. How one company addressed a drug's safety concerns head-on to win the confidence of FDA's advisors.

By Kate Rawson

A year ago, Pfizer Inc. 's inhaled insulin (Exubera) seemed to be on a fast track to nowhere. Once...

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