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Zydus Life gets tentative USFDA nod for Levomilnacipran

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Last Updated : Jan 16 2023 | 8:50 AM IST

The group now has 341 approvals and has so far filed over 431 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences' (formerly known as Cadila Healthcare) 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 (IQVIA MAT Sept. 2022).

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The company's consolidated net profit slumped 82.6% to Rs 522.50 crore despite of a 10% increase in total revenue from operations to Rs 4,134.7 crore in Q2 FY23 over Q2 FY22.

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Shares of Zydus Lifesciences fell 1.52% to Rs 441.25 on Friday, 13 January 2023.

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First Published: Jan 16 2023 | 8:30 AM IST

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