Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 200 µg/50 mL and 400 µg/100 mL Single Dose flexible containers (bags).
Aurobindo’s Dexmedetomidine HCl in 0.9% Sodium Chloride Injection is a therapeutic equivalent generic version of Hospira’s Precedex in 0.9% Sodium Chloride Injection. The product will be launched in January 2021.
Dexmedetomidine Hydrochloride in 0.9% sodium chloride injection is a relatively selective alpha2 -adrenergic agonist indicated for:
(a) sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting;
(b) sedation of non-intubated patients prior to and/or during surgical and other procedures.
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The approved product has an estimated market size of $228 million for the twelve months ending October 2020 according to IQVIA.
This is the 79th ANDA to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing injectable and ophthalmic products. Aurobindo now has a total of 459 ANDA approvals (431 Final approvals and 28 tentative approvals) from USFDA.