Lupin gets USFDA’s nod for Clobazam Tablets

17 Dec 2018 Evaluate

Lupin has received approval for its Clobazam Tablets, 10 mg and 20 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Lundbeck Pharmaceuticals, LLC's Onfi Tablets, 10 mg and 20 mg. Onfi Tablets, 10 mg and 20 mg had annual sales of approximately $601.2 million in the US (IQVIA MAT September 2018).

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.

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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