Zydus Pharmaceuticals (USA) Inc. (Zydus), a subsidiary of Zydus Lifesciences, has received preliminary 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) used to treat adults with Major Depressive Disorder (MDD). The drug will be manufactured in Moraiya, Ahmedabad, India, at the group’s formulation manufacturing facility.
According to IQVIA data, Levomilnacipran Extended-Release Capsules had annual sales of $85 million in the United States. Since the beginning of the filing process in FY 2003-04, the group has received 341 approvals and filed over 431 ANDAs.Zydus Lifesciences (previously Cadila Healthcare) is an Indian pharmaceutical company.