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Lupin has received approval from the US health regulator to market its generic Gabapentin tablets used for the treatment of postherpetic neuralgia in the American market.
According to a company statement, Lupin has received final approval to market its Gabapentin tablets USP in the strengths of 600 mg and 800 mg from the United States Food and Drug Administration (USFDA). Gabapentin tablets are the generic version of Pfizer Inc’s Neurontin tablets in the same strengths.
As per IQVIA MAT June 2018 data, Gabapentin tablets USP, 600 mg and 800 mg had annual sales of around $180.7 million in the US, the statement said.
The product is “indicated for the treatment of postherpetic neuralgia in adults and adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalisation, in adults and pediatric patients 3 years and older with epilepsy.”
Lupin shares were trading up by 0.01 per cent at Rs 907.70 on the BSE.
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