Zydus Lifesciences Ltd’s subsidiary, Zydus Pharmaceuticals (USA) Inc, has received tentative approval from the US Food and Drug Administration to market Levomilnacipran extended-release capsules in 20 mg, 40 mg, 80 mg, and 120 mg strengths, the company said in an exchange filing.
The drug is a generic version of Fetzima capsules. Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor used to treat major depressive disorder in adults.
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India.
According to the research firm IQVIA, levomilnacipran tablets sold $85 million in the United States in the fiscal year ended September.
The group now has 341 approvals and has so far filed over 431 abbreviated new drug applications since the commencement of the filing process in 2003-04 (Apr-Mar).