Zydus Lifesciences’ arm gets tentative approval to market Levomilnacipran Extended-Release Capsules

16 Jan 2023 Evaluate

Zydus Lifesciences’ 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. The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India.

Levomilnacipran Extended-Release Capsules had annual sales of $85 million in the United States according to IQVIA data. The group now has 341 approvals and has so far filed over 431 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
 

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