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Zydus Lifesciences Limited reported that it secured final approval from the United States Food and Drug Administration (USFDA) for manufacturing and marketing Gabapentin Tablets (Once-Daily), available in 300 mg and 600 mg variants.
The immediate launch of the product in the US market is anticipated following the approval. Gabapentin is primarily prescribed for managing Postherpetic Neuralgia, and Zydus will produce these tablets at its Moraiya-based formulation manufacturing facility in Ahmedabad.
- Also read: Lupin receives USFDA approval for Propranolol Hydrochloride extended-release capsules USP
The annual sales of Gabapentin Tablets (Once-Daily), 300 mg, and 600 mg, in the United States, were recorded at $85 million in November 2023, according to IQVIA. The company also said that this adds to Zydus’ record, comprising 384 approvals and over 448 filed Abbreviated New Drug Applications (ANDAs).
However, the shares were down by 2.27 per cent to ₹735 at 3 pm on the BSE.
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