Lupin Gets USFDA Nod for Clobazam Oral Suspension – CORPORATE ETHOS

Lupin Gets USFDA Nod for Clobazam Oral Suspension

By: | December 31, 2018

Dec 31: Mumbai-based pharma major Lupin Ltd on Monday announced that it has received approval for its Clobazam Oral Suspension, 2.5 mg/mL from the United States Food and Drug Administration (FDA) to market a generic version of Lundbeck Pharmaceuticals LLC’s Onfi Oral Suspension, 2.5 mg/mL.

Lupin’s Clobazam Oral Suspension, 2.5 mg/mL is the generic version of Lundbeck Pharmaceuticals, LLC’s Onfi Oral Suspension, 2.5 mg/mL. It is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older.

Clobazam Oral Suspension, 2.5 mg/mL had annual sales of approximately $ 260.2 million in the US (IQVIA MAT September 2018).