Zydus Lifesciences Gets USFDA Approval for Generic Gabapentin

Jan 25, 2024 15:34

Zydus Lifesciences receives USFDA approval to market generic Gabapentin tablets for postherpetic neuralgia, marking the first company to receive final approval for this strength.

Photograph: Courtesy Zydus.

New Delhi, Jan 25 (PTI) Zydus Lifesciences on Thursday said it has received approval from the US health regulator to market a generic medication to manage postherpetic neuraliga.

The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Gabapentin tablets in strengths of 300 mg and 600 mg, respectively, Zydus Lifesciences said in a regulatory filing.

The drug maker is the first company to receive final approval for generic Gabapentin tablets (300 mg and 600 mg), it added.

The product will be launched immediately in the US market, the drug firm stated.

As per IQVIA data, the product had an annual sales of USD 85 million in the US. Shares of Zydus were trading 2.27 per cent down at Rs 735.30 apiece on the BSE.

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Zydus Lifesciences Gets USFDA Approval for Generic Gabapentin

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