EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application ambrisentan tablets, 5mg and 10mg. Aurobindo Pharma’s ambrisentan tablets are an AB-rated generic equivalent to the reference listed drug (RLD), LETAIRIS Tablets, manufactured by Gilead Sciences Inc.
Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1), to improve exercise ability and delay clinical worsening. It is also indicated in combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.
Ambrisentan tablets has an estimated market size of US $58 Million for the twelve months ending May 2022, as per IQVIA.