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 percent sodium chloride injection, 200 g/50 mL and 400 g/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 percent sodium chloride injection. The company said the product will be launched in January 2021. Dexmedetomidine Hydrochloride in 0.9 percent 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.
Quoting IQVIA data, Aurobindo Pharma said the approved product has an estimated market size of USD 228 million for the 12 months ending October 2020.
Aurobindo now has a total of 459 abbreviated new drug application (ANDA) approvals (431 final and 28 tentative) from USFDA. Shares of Aurobindo Pharma were trading 0.95 per cent higher at Rs 904.30 apiece on BSE.