Cipla gets USFDA nod for new drug to treat pulmonary arterial hypertension

Drug major Cipla Thursday said it has received a final nod from the US health regulator for its abbreviated new drug application (ANDA) for Tadalafil tablets 20 mg, used to treat pulmonary arterial hypertension. The city-based firm in a statement said it has received final approval for its ANDA for Tadalafil tablets 20 mg from the United States Food and Drug Administration (USFDA).

Cipla's Tadalafil tablets 20mg is AB-rated generic therapeutic equivalent version of Eli Lilly & Co's Adcirca. It is a phosphodiesterase inhibitor indicated for the treatment of pulmonary arterial hypertension to improve exercise ability, it added.

As per IQVIA data, Adcirca and its generic equivalents had US sales of approximately USD 490 million for the 12-month period ending November 2018. The product is available for shipping immediately, Cipla said.