Zydus Cadila gets US FDA nod for new sedative injection

Drug firm Zydus Cadila has confirmed to have received the final approval from US health regulator FDA to market Dexmedetomidine Hydrochloride injection used for sedation of patients under intensive care.

Zydus Cadila in a regulatory filing said the approval from USFDA is to market Dexmedetomidine Hydrochloride injection 200 mcg (base)/ 2 ML and 100 mcg (base)/ ML single dose virals.

The manufacturing of the injection will be done at the group's formulations manufacturing facility at Moraiya, Ahmedabad.

The company said the drug is indicated for sedation of intubated and mechanically ventilated patients during treatment in an intensive care setting and for sedation of non-intubated patients prior to and/or during surgical and other procedures.