Zydus gets nod from USFDA for Venlafaxine and Pregabalin tablets

Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market two medicines: Venlafaxine extended-release tablets, USP 37.5 mg, 75 mg, 150 mg and 225 mg; and Pregabalin extended-release tablets, USP 82.5 mg, 165 mg and 330 mg. Venlafaxine is used to treat depression, anxiety, panic attacks and social anxiety disorder. It is expected to improve mood and energy levels in patients.

The medication is also expected to decrease fear, anxiety, unwanted thoughts and the number of panic attacks. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India. Pregabalin extended-release tablets are used to treat pain caused by nerve damage due to diabetes or shingles infection. This drug will also be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India. Venlafaxine extended-release tablets had annual sales of USD 46 mln in the United States (IQVIA MAT July 2022) and Pregabalin extended-release tablets had annual sales of USD 3 mln in the United States (IQVIA MAT June 2022).