Zydus Lifesciences Ltd announced on Wednesday that it has received final approval from the US health regulator to market its generic version of venlafaxine extended-release tablets used to treat depression.
The company also said the United States 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 infection with shingles (herpes zoster).
USFDA approval for venlafaxine extended-release tablets is for 37.5 mg, 75 mg, 150 mg and 225 mg strengths, Zydus Lifesciences said in a regulatory filing.
Venlafaxine is used to treat depression, anxiety, panic attacks, and social anxiety disorder. It has annual sales of $46 million in the United States, the company said citing IQVIA MAT in July 2022.
Additionally, Zydus Lifesciences said final USFDA approval to market pregabalin extended-release tablets is in 82.5 mg, 165 mg, and 330 mg strengths. The drug has achieved annual sales of $3 million in the United States according to IQVIA MAT data from June 2022.
Both drugs will be manufactured at the group’s formulation manufacturing plant in Ahmedabad SEZ, he added.
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