Zydus receives USFDA tentative approval for Gabapentin Tablets

The US Food and Drug Administration (USFDA) has granted tentative approval to Zydus Lifesciences’ subsidiary Zydus Pharmaceuticals (USA) Inc. for Gabapentin Tablets (Once-Daily), 300 mg and 600 mg (USRLD: Gralise Tablets). Gabapentin tablets are prescribed to treat Postherpetic Neuralgia (PHN). The drug will be produced at the group’s Moraiya formulation manufacturing facility. Gabapentin Tablets had annual sales in the United States of USD 90 million (IQVIA MAT Dec. 2022).

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