Zydus Lifesciences gets USFDA nod for generic version of Venlafaxine, Pregabalin
The drugs are used to treat nerve damage and depression
New Delhi, NFAPost: Zydus Lifesciences Ltd said it received final approval from the US health regulator to market its generic version of venlafaxine extended-release tablets used to treat depression.
The company said the US Food and Drug Administration (USFDA) has granted final approval for pregabalin extended-release tablets used to treat pain caused by nerve damage due to diabetes or shingles (herpes zoster) infection.
The approval granted by the USFDA for venlafaxine extended-release tablets is for strengths of 37.5 mg, 75 mg, 150 mg and 225 mg, Zydus Lifesciences said in a regulatory filing.
Venlafaxine treats depression, anxiety, panic attacks and social anxiety disorder. It had annual sales of $46 million in the US, the company said, citing IQVIA MAT July 2022.
Further, Zydus Lifesciences said the final approval granted by the USFDA to market pregabalin extended-release tablets is for strengths of 82.5 mg, 165 mg and 330 mg. The drug had annual sales of $3 million in the US, according to IQVIA MAT June 2022 data.
Both the drugs will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, it added.
