Zydus Pharmaceuticals (USA) Inc., a subsidiary of Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited), has received tentative approval from the US Food and Drug Administration to market Levomilnacipran Extended-Release Capsules in doses of 20mg, 40mg, 80mg, and 120mg (brand name Fetzima® Extended-Release Capsules).
Levomilnacipran, a serotonin and norepinephrine reuptake inhibitor, is intended for the treatment of Major Depressive Disorder in adults and will be produced at the company’s facility in Moraiya, Ahmedabad, India.
According to IQVIA data, Levomilnacipran Extended-Release Capsules had annual sales of $85 million in the United States as of September 2022.
Zydus has received 341 approvals and has filed over 431 Abbreviated New Drug Applications since the filing process began in the fiscal year 2003-04.
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