Granules India receives USFDA approval for Vigabatrin for Oral Solution

Granules India 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 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.

Vigabatrin for Oral Solution (brand and generic) products had U.S. sales of approximately $255 million MAT for the most recent twelve months ending in February 2020 according to IQVIA Health.

Granules now has a total of 27 ANDA approvals from US FDA (25 Final approvals and 2 tentative approvals).

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