Cipla gets USFDA nod for pulmonary arterial hypertension drug

Drug major Cipla Tuesday said it has received final approval from the United States Food and Drug Administration (USFDA) for Ambrisentan tablets, indicated for the treatment of pulmonary arterial hypertension. Cipla's Ambrisentan tablets 5 mg and 10 mg is AB-rated generic therapeutic equivalent version of Gilead Sciences Inc's Letairis, the Mumbai-based company said in a BSE filing.

Ambrisentan tablet is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening, it added.

Cipla said the US sales of Letairis tablets USP stood at USD 943 million in 2018.


"The product is available for shipping immediately," the company added.

Shares of Cipla closed 1.29 per cent lower at Rs 561.10 apiece on the BSE.