FDA approved once-daily Yosprala (Aralez), a fixed-dose combination of aspirin, an anti-platelet agent and omeprazole, a proton pump inhibitor (PPI), for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers.Here are the top 5 facts to know about Yosprala.
Even though an FDA panel recommended against approving a new drug to treat Duchenne muscular dystrophy in April, the agency granted accelerated approval to eteplirsen injection (Exondys 51, Sarepta Therapeutics) in mid-September.
In an era when legislators, pharmacy benefit managers and others continue to protest the high cost of hepatitis C drugs, new drugs to treat the disease are welcomed. FDA recently approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira XR, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 (GT1) infection, including those with cirrhosis. AbbVie already markets Viekira Pak, which competes with Harvoni and Sovaldi (Gilead Sciences).
FDA approved lixisenatide (Adlyxin, Sanofi-Aventis), a once-daily mealtime GLP-1 receptor agonist injection for type 2 diabetes, which will compete against the once-weekly pen dulaglutide (Trulicity, Eli Lilly) and the injectable liraglutide (Victoza, Novo Nordisk).