Zydus Obtains USFDA Approval for Generic Version of Venlafaxine, Pregabalin

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.

(Only the title and image of this report may have been edited by Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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