Drugmaker Aurobindo Pharma has received final approval from USFDA to manufacture and market Dexmedetomidine HCL 0.9% sodium chloride injection 200 µg (micro gram)/50 mL and 400 µg/100 mL single dose flexible containers (bags).
A therapeutic equivalent generic version of Hospira’s Precedex, it would be introduced launched in January, Aurobindo Pharma said on Wednesday. The estimated market size of the approved product was $228 million for the twelve months ended October 2020, a release said citing IQVIA numbers.
This is the 79th ANDA to be approved out of the company’s Unit IV formulation facility in Hyderabad, which is used for manufacturing injectable and ophthalmic products. The company now has a total of 459 ANDA approvals (431 Final approvals and 28 tentative approvals) from USFDA, Aurobindo Pharma said. The product is indicated for sedation of initially- intubated and mechanically-ventilated patients in an intensive-care setting and non-intubated patients prior to and/or during surgical and other procedures.
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