Zydus Lifesciences bags USFDA nod for Gabapentin Tablets (Once-Daily) for Postherpetic Neuraligia management
Following approval, the product will be launched immediately in the US.
Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Gabapentin Tablets (Once-Daily), 300 mg and 600 mg (USRLD: Gralise Tablets).
"Zydus is the first company to receive final approval for generic Gabapentin Tablets (Once-Daily), 300 mg and 600 mg," the Company claimed.
Following approval, the product will be launched immediately in the US.
Gabapentin is indicated for the management of Postherpetic Neuraligia (PHN).
Postherpetic neuralgia is neuropathic pain that happens due to damage to a peripheral nerve caused by the reactivation of the varicella zoster virus
The product will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad.
Gabapentin Tablets (Once-Daily), 300 mg and 600 mg had annual sales of USD 85 mn in the United States (IQVIA Nov. 2023). The group now has 384 approvals and has so far filed over 448* ANDAs since the commencement of the filing process in FY 2003-04.
Read also: Zydus Lifesciences secures USFDA nod for Pimavanserin capsules, tablets
Formerly known as Cadila Healthcare Limited, Zydus Lifesciences Limited is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the production of generic drugs. Cadila was founded in 1952 by Ramanbhai Patel.
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