Granules India Receives USFDA Nod for Generic Gabapentin Tablets

Granules India Ltd announced on Wednesday that the US Food and Drug Administration has approved its generic gabapentin tablets for the treatment of postherpetic neuralgia in adults. The US Food and Drug Administration (USFDA) has approved an abbreviated new drug application (ANDA) for Gabapentin tablets in strengths of 600 mg and 800 mg, according to Granules India in a regulatory filing.

These tablets are bioequivalent to the reference listed drug product, Viatris Specialty LLC's Neurontin Tablets, 600 mg and 800 mg. Gabapentin tablets are approved for the treatment of postherpetic neuralgia in adults, as well as for the treatment of partial onset seizures with and without secondary generalisation in adults and paediatric patients aged 3 years and older with epilepsy, according to the company.

According to IQVIA/IMS Health January 2023 data, gabapentin tablets had annual sales of approximately USD 145 million in the United States. Granules now has a total of 55 ANDA approvals from the USFDA, including 53 final approvals and two tentative approvals, according to the company.