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Cipla gets USFDA nod for generic pulmonary arterial hypertension drug

Drug major Cipla on Thursday said that 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). The product is a generic version of Eli Lilly & Co’s Adcirca tablets, Cipla said in a statement.

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

Shares of Cipla were trading at Rs 533.90 per scrip on the BSE, up 1.13 per cent from the previous close.

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