Lupin gets USFDA tentative approval for generic tablets to treat Erectile Dysfunction
New Delhi: Drug maker Lupin recently said it has received tentative approval from the US health regulator for Tadalafil tablets, used to treat erectile dysfunction and enlarged prostate, in the American market.
The company has received approval from the US Food and Drug Administration (USFDA) to market its product which is a generic version of Eli Lilly and Company's Adcirca tablets.
Tadalafil is used to treat the symptoms of two conditions found in men: benign prostatic hyperplasia (BPH) and erectile dysfunction(ED). Tadalafil is also used to treat pulmonary arterial hypertension (PAH).
According to IQVIA MAT September data, Adcirca tablets, 20 mg, had annual sales of around USD 503.8 million in the US.
Lupin is a pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.