FDA Approvals

Drug maker pays out millions over EpiPen chargesAs Mylan continues to face criticism over price hikes on its EpiPen epinephrine injection, the company agreed to a $465 million settlement with the U.S. Department of Justice and other agencies for overcharging on the EpiPen.
Cystic fibrosis drug approved for younger patientsFDA recently expanded the use of lumacaftor/ivacaftor (Orkambi, Vertex Pharmaceuticals) to treat cystic fibrosis in children aged 6 to 11 years who have two copies of the F508del mutation.
First "artificial pancreas" for diabetes approved, plus 2 more FDA actionsFDA recently approved several medications and devices across several therapy areas: diabetes, weight loss and rare, auto-inflammatory diseases. Here are the top 3 new approvals.
FDA approves biosimilar to HumiraFDA’s pace of biosimilar approvals is picking up, as it approved two major drugs for rheumatoid arthritis and other inflammatory diseases in the past month.
Invokamet extended-release approved for diabetesFDA recently approved an expanded use for Invokamet (Janssen): Invokamet XR, an extended-release combination drug to treat type 2 diabetes. The original Invokamet was approved by FDA in 2014.
New drug approved for heart patientsFDA 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.
FDA approves first drug for Duchenne muscular dystrophyEven 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.
New biosimilar for RA to save millionsFDA’s approval of a new biosimilar—the third FDA-approved biosimilar—stands to save the US healthcare system millions of dollars.
Abuse-deterrent opioid pain drug approvedFDA recently approved the only oxycodone with oral abuse-deterrent features.
EpiPen discounts offered after pricing flapAfter protests by patients, parents and Congressional representatives, Mylan said it would offer discounts on its epinephrine EpiPen Auto-Injector treatment to stop allergic reactions.