Lupin gets USFDA nod to Tadalafil to treat pulmonary arterial hypertension

Tadalafil is also used to treat the symptoms of two conditions found in men: benign prostatic hyperplasia (BPH) and erectile dysfunction(ED). Tadalafil under the name of Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate).

Mumbai: Drug firm Lupin on Thursday said it has received approval from the US health regulator to market a generic version of Tadalafil tablets, used to treat pulmonary arterial hypertension.

The company has received approval from the US Food and Drug Administration (USFDA) to market a generic version of Eli Lilly and Company’s Adcirca tablets in 20 mg strength, Lupin said in a statement.

It is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability.

Pulmonary hypertension is a life-threatening condition that gets worse over time, but treatments can help your symptoms so you can live better with the disease. Having pulmonary arterial hypertension (PAH) means that one has high blood pressure in the arteries that go from heart to lungs. It's different from having regular high blood pressure. With PAH, the tiny arteries in your lungs become narrow or blocked. Eventually, it can lead to heart failure.

Tadalafil is also used to treat the symptoms of two conditions found in men: benign prostatic hyperplasia (BPH) and erectile dysfunction(ED). Tadalafil under the name of Cialis is used to treat erectile dysfunction (impotence) and symptoms of benign prostatic hypertrophy (enlarged prostate).

Also Read: Lupin gets USFDA tentative approval for generic tablets to treat Erectile Dysfunction

As per IQVIA MAT December 2018 data, Lupin said, the Tadalafil tablets, 20 mg had annual sales of around USD 474.3 million in the US.

Lupin is a pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds a position in the Anti-TB segment.

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