Lupin gets USFDA’s nod for Clobazam Oral Suspension

31 Dec 2018 Evaluate

Lupin has received approval for its Clobazam Oral Suspension, 2.5 mg/mL from the United States Food and Drug Administration (USFDA) to market a generic version of Lundbeck Pharmaceuticals LLC's Onfi Oral Suspension, 2.5 mg/ml. Clobazam Oral Suspension, 2.5 mg/mL had annual sales of approximately $260.2 million in the US (IQVIA MAT September 2018).

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.

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

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