Lupin has received final approval to market its Gabapentin tablets USP in the strengths of 600 mg and 800 mg from USFDA for postherpetic neuralgia
New Delhi: Drug firm Lupin said it 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.
The company 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), Lupin said in a statement.
The company’s tablets are a generic version of Pfizer Inc’s Neurontin tablets in the same strengths, it added.
As per the IQVIA MAT June 2018 data, Gabapentin tablets USP, 600 mg and 800 mg had annual sales of around USD 180.7 million in the US, Lupin 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 generalization, in adults and pediatric patients 3 years and older with epilepsy.”