Granules India gets USFDA nod for Vigabatrin for Oral Solution
Hyderabad: Granules India Limited has announced that the US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of Granules India Limited for Vigabatrin for Oral Solution USP, 500 mg. It is bioequivalent to the reference listed drug product (RLD), Sabril® (vigabatrin) for Oral Solution, 500 mg, of Lundbeck Pharmaceuticals LLC.
Vigabatrin for Oral Solution is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Vigabatrin for Oral Solution is not indicated as a first-line agent for complex partial seizures.
Vigabatrin for Oral Solution is also indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.
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