Zydus Lifesciences arm bags USFDA okay for Major Depressive Disorder drug Levomilnacipran Extended-Release
Ahmedabad: Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) subsidiary Zydus Pharmaceuticals (USA) Inc. (Zydus) has received tentative approval from the United States Food and Drug Administration (USFDA) to market Levomilnacipran Extended-Release Capsules, 20 mg, 40 mg, 80 mg, and 120 mg (USRLD: Fetzima Extended-Release Capsules).
Levomilnacipran is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of Major Depressive Disorder (MDD) in adults.
Major depressive disorder (MDD) is a mental disorder characterized by at least two weeks of pervasive low mood, low self-esteem, and loss of interest or pleasure in normally enjoyable activities.
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India.
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Levomilnacipran Extended-Release Capsules had annual sales of USD 85 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).
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