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