FDA Approvals - APP Pharmaceuticals Receives Final Approvals for Additional Dosages of Granisetron
APP Pharmaceuticals Receives Final Approvals for Additional Dosages of Granisetron Hydrochloride Injection, USP (Centre Daily Times)
APP Pharmaceuticals, Inc. (Nasdaq:APPX), a leading manufacturer of multi-source and branded injectable pharmaceutical products, today announced that it has received final approvals from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Applications (ANDAs) for Granisetron Hydrochloride Injection, 1 mg/mL, 1 mL single dose, and 1mg/mL, 4mL multiple dose vials, the generic ...
Revised Study Maintains Link Between FDA Approvals Made Soon Before Deadlines, Safety Risks (Medical News Today)
Harvard University professor Daniel Carpenter has made revisions to a study published in March that found prescription drugs hurried through the FDA approval process are more likely to later be linked to safety risks, but he maintains that the study's conclusions are still accurate, the Wall Street Journal reports.