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Hospira, Food and Drug Administration neurology news

September 15, 2014 7:00 AM UTC

The U.S. District Court for the District of Maryland sided with FDA in a suit challenging whether the agency could approve generic versions of a sedative so long as the generic labels do not include an approved use covered by a method of use patent. The court said FDA may approve generics of Precedex dexmedetomidine from Hospira for procedural sedation if the label omits ICU sedation, despite that procedural sedation may at times occur in an ICU. Hospira is appealing the decision.

According to its U.S. label, Precedex is approved to sedate initially intubated and mechanically ventilated patients in an ICU setting; and to sedate non-intubated patients prior to and/or during surgeries and other procedures. A method of use patent covering Precedex in non-intubated patients in an ICU setting expires in October 2019. ...