Aurobindo Pharma receives USFDA Approval for Dexmedetomidine HCL in 0.9% Sodium Chloride Injection

Aurobindo Pharma Limited 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. The approved product has an estimated market size of US$ 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 & ophthalmic products. Aurobindo now has a total of 459 ANDA approvals (431 Final approvals and 28 tentative approvals) from USFDA.

Shares of AUROBINDO PHARMA LTD. was last trading in BSE at Rs.895.75 as compared to the previous close of Rs. 910.9. The total number of shares traded during the day was 111274 in over 3811 trades.

The stock hit an intraday high of Rs. 917.55 and intraday low of 888.65. The net turnover during the day was Rs. 100404987.

Source : Equity Bulls

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