USFDA approves Zydus Cadila’s sedative injection

Zydus Cadila provides total healthcare solutions ranging from formulations, active pharmaceutical ingredients and animal healthcare products to wellness products.

The company has received final approval from US health regulator to market Dexmedetomidine Hydrochloride injection used for sedation of intubated and mechanically ventilated patients.

The approval from USFDA is to market Dexmedetomidine Hydrochloride injection 200 mcg (base)/ 2 ML and 100 mcg (base)/ ML single dose virals.

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

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.