FDA Approvals

Gilead promises generic versions of new hepatitis drugAfter Gilead received FDA approval for a new drug for chronic hepatitis B virus (HBV), it said low-cost, generic versions would also soon be available. That is good news for Gilead, which has been targeted by Congressional representatives for the high cost of Sovaldi and Harvoni hepatitis C treatments.
Breakthrough lymphoma drug on the horizonFDA granted Breakthrough Therapy Designation to brentuximab vedotin (Adcetris, Seattle Genetics) to treat patients with the most common subtypes of lymphoma.
First olmesartan generics approved for hypertensionIn a big move for patients who take blood pressure medication on a regular basis, FDA last week approved the first generic versions of 4 drugs that contain the blood pressure-lowering medication olmesartan medoxomil (Benicar, Daiichi Sankyo).
Lung cancer drug approvedSoon after FDA granted accelerated approval for atezolizumab (Tecentriq, Genentech) to treat bladder cancer, the agency okayed the drug to treat metastatic non-small cell lung cancer (NSCLC).
Big savings expected with new generic antipsychoticFDA tentatively approved the abbreviated new drug application (ANDA) for generic quetiapine fumarate extended-release tablets (brand Seroquel XR, AstraZeneca) to treat schizophrenia and manic/mixed episodes associated with bipolar disorder.
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.