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Granules India has received approval from the US Food and Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for gabapentin tablets.
The approved product is a bioequivalent of the reference listed drug product (RLD) Neurontin tablets of Viatris Specialty LLC.
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The annual US market for gabapentin tablets is approximately $145 million, the Hyderabad-based company said in a release.
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 paediatric patients three years and older with epilepsy.
Also read: Glenmark gets USFDA nod for generic drug with 180-day exclusivity
Granules now has 55 ANDA approvals from US FDA (53 final approvals and two tentative approvals), the release added.
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