Zydus Lifesciences Arm Gets U.S. FDA Nod For Drug To Treat Depression

Zydus Lifesciences Ltd. on Monday said its U.S. unit has received tentative approval from the U.S. Food and Drug Administration to market generic Levomilnacipran extended-release capsules used to treat depression.

Zydus Pharmaceuticals (USA) Inc. received a tentative approval from the U.S. drug regulator to market Levomilnacipran extended-release capsules of strengths 20 mg, 40 mg, 80 mg, and 120 mg, Zydus Lifesciences said in a regulatory filing.

The drug will be manufactured at the group's formulation manufacturing facility at Moraiya in Ahmedabad, it added.

Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder in adults, the drug maker said.

The capsules had annual sales of $85 million (Rs 694.22 crore) in the U.S., the company said citing IQVIA MAT September 2022 data.