Zydus Lifesciences Ltd on Monday said its US arm has received tentative approval from the US Food and Drug Administration to market generic Levomilnacipran extended-release capsules used to treat depression.
The tentative approval granted by the US Food and Drug Administration (USFDA) to Zydus Pharmaceuticals (USA) Inc is to market Levomilnacipran extended-release capsules of strengths 20 mg, 40 mg, 80 mg, and 120 mg, the company 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 (MDD) in adults, Zydus Lifesciences said.
The capsules had annual sales of USD 85 million in the US, the company said citing IQVIA MAT September 2022 data.
