Lupin receives US FDA approval for Clobazam tabs

The drug is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older

Lupin has received approval for its Clobazam tablets, 10 mg and 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Lundbeck Pharmaceuticals’ Onfi Tablets, 10 mg and 20 mg.
Lupin’s Clobazam Tablets, 10 mg and 20 mg is the generic version of Lundbeck Pharmaceuticals’ Onfi Tablets, 10 mg and 20 mg. It is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients two years of age or older.

Onfi Tablets, 10 mg and 20 mg had annual sales of approximately $601.2 million in the US.