USFDA nod to Granules India postherpetic neuralgia drug Gabapentin
The medicine is also indicated as 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.
Hyderabad: 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.
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 the management of postherpetic neuralgia in adults. Postherpetic neuralgia is neuropathic pain that occurs due to damage to a peripheral nerve caused by the reactivation of the varicella zoster virus.
The medicine is also indicated as 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.
Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. The company manufactures high-quality API, FD, PFI and Speciality Products with a focus on customer centricity. Granules products are distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, US and UK. The Company has 7 manufacturing facilities out of which 6 are in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.