The U.S. Food and Drug Administration reported 1,171 generic drug approvals (935 full approvals and 236 tentative approvals) for fiscal year 2019, up from the previous all-time record total of 971 during 2018.
“We have been taking new policy steps at the FDA to support downward pressure on drug prices by helping to clear a path for more efficient generic development,” says FDA Commissioner Scott Gottlieb, M.D.
The U.S. FDA approved Amneal Pharmaceuticals’ generic version of Novartis’ Exelon Patch (Rivastigmine Transdermal System) for dementia related to Alzheimer’s and Parkinson’s diseases.
U.S. Food and Drug Administration Commissioner Scott Gottlieb announced that the regulatory agency is relaunching the Drug Competition Action Plan in 2019 with some additional initiatives.
While the nation’s media was focusing on the unsuccessful attempts by Republicans to pass a successor to Obamacare, a fascinating sideshow has developed in nearby White Oak, Maryland, home of the Food and Drug Administration.
The U.S. FDA is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives.