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Lupin gets USFDA nod for generic Clobazam Tablets


Lupin gets USFDA nod for generic Clobazam Tablets

New Delhi: Pharma major Lupin recently 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. Clobazam belongs to the class of medications known as benzodiazepines. It is used as an add-on to other antiseizure medications when extra treatment for control of seizures is needed.

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

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

Also Read: Lupin receives tentative USFDA nod for Dimethyl Fumarate Delayed-Release Capsules



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