Mumbai, India; April 30, 2019: Cipla Limited and its subsidiary Cipla USA, Inc., (hereafter referred to as “Cipla”) announce receipt of final approval for the Abbreviated New Drug Application (ANDA) for Ambrisentan Tablets 5mg & 10mg from the United States Food and Drug Administration (US FDA).
Cipla’s Ambrisentan Tablets 5mg & 10mg is AB-rated generic therapeutic equivalent version of Gilead Sciences, Inc’s Letairis®. 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.
The U.S. Sales of Letairis® Tablets USP stood at $943 million in 2018. The product is available for shipping immediately.