Lupin gets USFDA’s tentative approval for Tadalafil Tablets

17 Dec 2018 Evaluate

Lupin has received tentative approval for its Tadalafil Tablets USP, 20 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Eli Lilly and Company's (Lilly) Adcirca Tablets, 20 mg. Adcirca Tablets, 20 mg, had annual sales of approximately $503.8 million in the US (IQVIA MAT Sept ember 2018)

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.

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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