The US Food and Drug Administration (USFDA) has granted final approval to Zydus Lifesciences’ subsidiary Zydus Worldwide DMCC (Zydus) to market Selexipag tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg (USRLD: Uptravi tablets). Selexipag tablets’ 180-day shared generic drug exclusivity period is available to Zydus because it was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification.
To slow the progression of the disease and lower the likelihood of hospitalisation for PAH, selexipag tablet is recommended for use in adults with pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs).
The group’s formulation manufacturing facility in Ahmedabad SEZ, India, will produce the medication.
The group has filed over 431 ANDAs since the filing process began in FY 2003–04, and it currently has 338 approvals.
Zydus Lifesciences is a multinational, discovery-driven company that develops, produces, and markets a wide range of medical treatments.