Lupin receives tentative USFDA approval for Tadalafil Tablets

Lupin announced that it has received tentative 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 (Lilly) Adcirca Tablets, 20 mg.

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

Adcirca Tablets, 20 mg, had annual sales of approximately USD $ 503.8 million in the US (IQVIA MAT September 2018).

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