Lupin receives USFDA approval for anti-depressant drug

Homegrown pharma major Lupin Ltd on Thursday said it has received approval from the US health regulator to market its generic version of Desvenlafaxine extended-release tablets used for treating depression.

The approval granted by the US Food and Drug Administration (FDA) is for the abbreviated new drug application (ANDA) Desvenlafaxine extended-release tablets of strength 25 mg, the company said in a regulatory filing.

It is the generic equivalent of Pristiq, extended-release tablets, 25 mg of PF PRISM C.V, it added.

"The product will be manufactured at Lupin's facility in Goa, India," the company said.

Citing IQVIA MAT December 2021 data, Lupin said Desvenlafaxine extended-release tablets, 25 mg, had an estimated annual sales of USD 14 million in the US.