Zydus Lifesciences Limited’s subsidiary, Zydus Pharmaceuticals (USA) Inc., has received tentative approval from the United States Food and Drug Administration (USFDA) for Gabapentin Tablets, the company said via an exchange filing.
The recommended daily dose is 300 mg or 600 mg (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).
The group now has 343 approvals and has so far filed over 440 ANDAs since the commencement of the filing process in FY 2003-04.
