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).
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.