Cipla Receives Final Approval for Generic Version of Gilead Sciences, Inc’s Letairis
The global pharmaceutical company is focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America and key regulated and emerging markets.
Cipla Limited and its subsidiary Cipla USA, Inc., on Tuesday, announced that the company had received the final approval for the Abbreviated New Drug Application (ANDA) for Ambrisentan Tablets 5mg & 10mg from the United States Food and Drug Administration (US FDA). The global pharmaceutical company is focused on agile and sustainable growth, complex generics, and deepening portfolio in its home markets of India, South Africa, North America and key regulated and emerging markets.
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. Cipla has proven strengths in the respiratory, anti-retroviral, urology, cardiology and CNS segments.
The U.S. Sales of Letairis® Tablets USP stood at $943 million in 2018. The product is available for shipping immediately.