Granules India announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Gabapentin Tablets USP, 600 mg and 800 mg.
It is bioequivalent to the reference listed drug product (RLD), Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty LLC.
Gabapentin tablets are indicated for management of postherpetic neuralgia in adults; and as an adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalisation, in adults and pediatric patients three years and older with epilepsy.
Granules now have a total of 55 ANDA approvals from US FDA (53 final approvals and two tentative approvals). The current annual US market for Gabapentin Tablets is approximately $145 million, according to MAT Jan 2023, IQVIA/IMS Health.