fda-approval-letter
PHARMACY

FDA gives nod, tentative OK for Lupin’s 2 generics

BY Sandra Levy

Lupin has received the Food and Drug Administration’s clearance for clobazam tablets, in 10-mg and 20-mg dosage strengths.

Clobazam is the generic version of Lundbeck’s Onfi tablets.

The product is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome in patients 2 years of age or older.

The product had a market value of roughly $601.2 million, according to September 2018 IQVIA data.

Lupin also has received tentative approval from the FDA for tadalafil tablets in 20-mg dosage strength.

The product is the generic version of Lilly’s Adcirca tablets, 20 mg. It is indicated for the treatment of pulmonary arterial hypertension to improve exercise ability.

The product had a market value of roughly $503.8 million, according to September 2018 IQVIA data.

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