Mumbai, Dec 14 ( Agency) Pharma major, Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.9 pc Sodium Chloride Injection, 200 μg/50 mL and 400 μg/100 mL Single Dose flexible containers (Bags). Aurobindo’s Dexmedetomidine HCl in 0.9 pc Sodium Chloride Injection is a therapeutic equivalent generic version of Hospira’s Precedex in 0.9 pc Sodium Chloride Injection. The product will be launched in January 2021.
Dexmedetomidine Hydrochloride in 0.9 pc sodium chloride injection is a relatively selective alpha – adrenergic agonist 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. The approved product has an estimated market size of USD 228 million for the twelve months ending October 2020 according to IQVIA.