BRIEF—US FDA approval for Zydus levomilnacipran generic

The US subsidiary of Indian generics major Zydus Lifesciences (NYSE: ZYDUSLIFE) (formerly known as Cadila Healthcare) has received tentative approval from the US Food and Drug Administration (FDA) to market levomilnacipran extended-release capsules, 20mg, 40mg, 80mg and 120mg.

This is a generic version of Fetzima, which was developed by France-based independent pharma company Pierre Fabre and was licensed in the USA to Forest Laboratories which ceased operations in 2014.

Le000.vomilnacipran 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 Zydus’ formulation manufacturing facility at Moraiya, Ahmedabad, India.

Levomilnacipran extended-release capsules had annual sales of $85 million in the USA according to IQVIA data (MAT September 2022).