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ARTICLE | Company News

Hospira, Food and Drug Administration neurology news

September 1, 2014 7:00 AM UTC

Hospira filed suit against FDA in the U.S. District Court for the District of Maryland alleging that FDA’s decision to approve generic versions of Hospira’s Precedex dexmedetomidine so long as the labels for the generics do not indicate use in an intensive care unit (ICU) setting is “wrong and unlawful.” 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.

Hospira is arguing that FDA’s “proposed carved-out indications” for the generics’ labels overlap with the use code for Precedex. According to Hospira’s complaint, the use code states “ICU sedation, including sedation of non-intubated patients prior to and/or during surgical and other procedures.” Use codes are descriptions of the methods of use protected by patents, which FDA uses to evaluate whether an ANDA infringes patents for a branded drug. A method of use patent covering Precedex in non-intubated patients in an ICU setting expires in October 2019. ...