Pharmaceutical manufacturer Zydus Cadila said that it has received approval from the United States Food and Drug Administration for the sales of a generic equivalent of Gilead Sciences’ hypertension drug Letairis.
Ambrisentan tablets had sales of $943 million in the US market in 2018, marking it among the bigger drugs in the market.
Ambrisentan tablets are also sold under the brand names of Volibris in the European Union and Pulmonext in India.
The drug will be sold in doses of 5 mg and 10 mg and will be manufactured at the company’s facility in Ahmedabad.
With the latest nod, Zydus has so far received 258 approvals and filed over 350 applications for the sales of its generic drug.
Headquartered in Ahmedabad, Zydus Cadila has manufacturing sites and research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim and even in the United States and Brazil.