Zydus Lifesciences on Monday announced that it has received tentative approval from United States Food and Drug Administration (USFDA) for Gabapentin Tablets (Once-Daily), 300 mg and 600 mg (USRLD: Gralise Tablets).
Gabapentin comes under the class of medications called anticonvulsants. The drug helps in treating seizures by decreasing abnormal excitement in the brain.
It is also a first-line medication for the treatment of neuropathic pain caused by diabetic neuropathy, postherpetic neuralgia, and central pain.
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya.
According to data by IQVIA MAT in December 2022, Gabapentin Tablets had annual sales of USD 90 million in the United States.