Zydus Lifesciences arm gets USFDA nod for Postherpetic Neuralgia drug Gabapentin
Ahmedabad: Pharma major Zydus Lifesciences Limited has announced that the company's 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). Postherpetic neuralgia is neuropathic pain that occurs due to damage to a peripheral nerve caused by the reactivation of the varicella zoster virus.
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.
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Zydus Lifesciences Limited (Formerly known as Cadila Healthcare Limited), an Indian Pharmaceutical company is a fully integrated, global healthcare provider. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals.
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