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.
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