Granules India Limited announced today 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, via an exchnage filing.
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 generalization, in adults and pediatric patients 3 years and older with epilepsy.
Granules now have a total of 55 ANDA approvals from US FDA (53 Final approvals and 2 tentative approvals).
The current annual U.S. market for Gabapentin Tablets is approximately $145 Million, according to MAT Jan 2023, IQVIA/IMS Health.
