FDA issued two important drug warnings this week: one linking certain diabetes medications to bladder cancer and another about the use of general anesthetic and sedation drugs during pregnancy.
FDA recently approved bevacizumab (Avastin, Genentech) for patients with platinum-sensitive recurrent epithelial ovarian (psOC), fallopian tube or primary peritoneal cancer.
FDA’s approval of a new indication for empagliflozin (Jardiance, Eli Lilly and Boehringer Ingelheim) could net the pharmaceutical manufacturers more than $1 billion.
Two new diabetes drugs, both long-acting injectable insulin products, were simultaneously approved by FDA.
FDA granted Breakthrough Therapy Designation to brentuximab vedotin (Adcetris, Seattle Genetics) to treat patients with the most common subtypes of lymphoma.
After 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.
In 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).
Soon 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).
FDA 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.
As 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.