Aurobindo Pharma gains after USFDA approval for sedative drug

Aurobindo Pharma rose 1.13% to Rs 905.95 after the company said it received US drug regulator's approval for dexmedetomidine HCL in 0.9% sodium chloride injection.

Aurobindo Pharma announced that it 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. The product is a therapeutic equivalent generic version of Hospira's Precedex. The product will be launched in January 2021.

Dexmedetomidine hydrochloride in 0.9% sodium chloride injection indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting; sedation of non-intubated patients prior to and/or during surgical and other procedures. 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 & ophthalmic products. Aurobindo now has a total of 459 ANDA approvals (431 Final approvals and 28 tentative approvals) from USFDA.

The drug maker's consolidated net profit rose 26% to Rs 805.65 crore on 15.6% rise in net sales to Rs 6,377.91 crore in Q2 September 2020 over Q2 September 2019.

Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients.

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