Aurobindo gets FDA nod for generic Precedex
Drug major Aurobindo Pharma On Wednesday said it has received final approval from the US health regulator for generic of Precedex injection, used for sedation of patients.
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Hyderabad: Drug major Aurobindo Pharma On Wednesday said it has received final approval from the US health regulator for generic of Precedex injection, used for sedation of patients.
The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.9 per cent sodium chloride injection, 200 µg/50 mL and 400 µg/100 mL single dose flexible containers (bags), Aurobindo Pharma said in a regulatory filing.
Aurobindo said the approved product is a therapeutic equivalent generic version of Hospira's Precedex in 0.9 per cent sodium chloride injection. The company said the product will be launched in January 2021.
Dexmedetomidine Hydrochloride in 0.9 per cent sodium chloride injection is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting and sedation of non-intubated patients prior to and/or during surgical and other procedures.
