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 USD 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 USD 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.