Zydus Lifesciences gets FDA tentative approval for Gabapentin Tablets

Zydus Lifesciences said that its subsidiary Zydus Pharmaceuticals (USA) has secured tentative approval for once-daily Gabapentin Tablets, 300 mg and 600 mg from the US Food and Drug Administration (FDA).

The approved product is the generic of Gralise Tablets, which are used for managing postherpetic neuralgia (PHN).

As per IQVIA MAT December 2022, the annual sales of Gabapentin Tablets in the US were $90 million.

Zydus Lifesciences gets FDA tentative approval for Gabapentin Tablets. Photo courtesy of Zydus Cadila.

Zydus Lifesciences said that it will manufacture Gabapentin Tablets at its formulation manufacturing plant in Moraiya, Gujarat.

The Indian pharma company has 343 approvals to date and has so far filed more than 440 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.