Friday, 19 April 2019

Lupin gets FDA approval for Clobazam oral suspension

01 January 2019 | News

It is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older

Pharma major Lupin 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 USD 260.2 million in the US (IQVIA MAT September 2018).

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