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The European Medicines Agency has ordered drug companies to review their products within the next six months for contamination with nitrosamines. Read More
The FDA’s Office of Prescription Drug Promotion (OPDP) sent a warning letter to Galt Pharmaceuticals for intentionally sending an email to doctors about its insomnia pill Doral (quazepam) that left out the fact that the drug is a benzodiazepine, a class-four controlled substance. Read More
Johnson & Johnson and its Janssen subsidiary appealed Oklahoma’s $572 million opioid court verdict to the state’s Supreme Court, arguing they were unjustly singled out as responsible for the opioid crisis. Read More
Drugmakers increased the list prices of their drugs far beyond the inflation rate between 2017 and the first quarter of 2019, California found in a first-of-its kind study of 1,020 drugs based on the state’s mandatory wholesale price reporting requirements. Read More
Two FDA advisory committees voted 16-8 on Thursday against recommending pediatric labeling for Endo Pharma’s Opana IR (immediate-release oxymorphone). Read More