Zydus Cadila gets US FDA nod for sedative injection

Zydus Cadila 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 US FDA is to market Dexmedetomidine Hydrochloride injection 200 mcg (base)/ 2 ML and 100 mcg (base)/ ML single dose virals, Zydus Cadila said in a regulatory filing.

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, the company said.

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