The US Food and Drug Administration (FDA) has granted six months pediatric exclusivity for Hospira's Precedex (dexmedetomidine HCl) injection in the US.
Precedex, an alpha-2 agonist, is approved for use only in adults and the US regulator is reviewing its pediatric use.
Precedex is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care environment and sedation of non-intubated patients before and/or during surgical and other procedures.
Hospira US president Thomas Moore said, "Hospira is excited about the approval of Precedex in a premix version that will help reduce potential for medication errors, enhance patient safety and increase pharmacy efficiency."
The company also won the FDA approval for a premix version of Precedex, a ready-to-use product for clinicians, and expects to make it available in 200mcg/50mL and 400mcg/100mL presentations shortly.
