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( 07 Feb 2019)
Cipla gets USFDA nod for generic pulmonary arterial hypertension drug

Drug major Cipla Thursday said it has received nod from the US health regulator for its generic Tadalafil tablets used for treatment of pulmonary arterial hypertension.

The company has received final approval for its abbreviated new drug application (ANDA) for Tadalafil tablets in the strength of 20 mg from the United States Food and Drug Administration (USFDA), Cipla said in a statement.

The product is a generic version of Eli Lilly & Co's Adcirca tablets, it added.

According to IQVIA (IMS Health), Adcirca and its generic equivalents had US sales of about USD 490 million for the 12-month period ended November 2018, the statement said.

The company's product is available for shipping immediately, it added.

The Tadalafil tablets are indicated for the treatment of pulmonary arterial hypertension to improve exercise ability, it said.