FDA

FDA | August 03, 2016

U.S. Food and Drug Administration approved the first generic version of Tamiflu (oseltamivir phosphate), a widely used medication for the treatment of the flu (influenza A and B) in patients two weeks of age and older who have had flu symptoms for no more than 48 hours; and prevention of the flu in patients one year of age and older. Tamiflu was approved in 1999...

FDA | July 26, 2016

The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections....

FDA | May 05, 2016

The U.S. Food and Drug Administration is reminding health care professionals and patients not to use drugs intended to be sterile that were produced by Medaus Inc., due to lack of sterility assurance. The FDA has issued a formal request to the Birmingham, Alabama, compounding pharmacy to recall all non-expired lots of drug products intended to be sterile....

FDA | July 12, 2016

The U.S. Food and Drug Administration today approved safety labeling changes for a class of antibiotics, called fluoroquinolones, to enhance warnings about their association with disabling and potentially permanent side effects and to limit their use in patients with less serious bacterial infections. "Fluoroquinolones have risks and benefits that should be considered very carefully," said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation...