Lupin receives FDA approval for Tadalafil

February 07, 2019 | Thursday | News

It is indicated for the treatment of pulmonary arterial hypertension

Pharma major Lupin announced that it has received approval for its Tadalafil Tablets USP, 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s Adcirca Tablets, 20 mg.

Lupin’s Tadalafil Tablets USP, 20 mg is the generic version of Eli Lilly and Company’s Adcirca Tablets, 20 mg. It is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability.

Tadalafil Tablets, 20 mg had annual sales of approximately USD 474.3 million in the US (IQVIA MAT December 2018).