Lupin: receives US FDA approval for Clobazam Tablets, 10 mg and 20 mg

Pharma major Lupin announced that it 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, LLC’s Onfi Tablets, 10 mg and 20 mg.

Lupin’s Clobazam Tablets, 10 mg and 20 mg is the generic version of Lundbeck Pharmaceuticals, LLC’s Onfi Tablets, 10 mg and 20 mg. It is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.

Onfi Tablets, 10 mg and 20 mg had annual sales of approximately USD $601.2 million in the US (IQVIA MAT September 2018).

https://www.marketscreener.com/LUPIN-9059009/news/Lupin-receives-US-FDA-approval-for-Clobazam-Tablets-10-mg-and-20-mg-27770050/