Europe has been pushing the U.S. in trade negotiations to accept their inspections of European drugmakers in lieu of doing their own, and vice versa, but the approach the FDA and European regulators have taken to problems at a Ranbaxy Laboratories plant illustrate why this has become a contentious issue.
Regulators in Vietnam have banned drug imports from dozens of companies, saying they are substandard.
FDA's May 28 approval of Natesto, the first nasally delivered testosterone gel for hypogonadism, came just in time for Canada's Trimel Pharmaceuticals, which had just $18 million left on hand at the beginning of the year.
In the wake of a lawsuit brought by two California counties against five manufacturers of prescription painkillers, the city of Chicago has filed a suit of its own. Chicago is suing the same five pharma companies--alleging, much like California does, that they overstated the benefits of opioid painkillers while deceiving the public about the risks.
Just after Pfizer made a massive drug recall in March, Indian manufacturer Zydus Cadila is now scrambling to pull 10,200 bottles of allergy pills from shelves manufactured by its U.S. unit after the discovery of a blood pressure pill.
Novartis has to face a kickbacks lawsuit filed by the U.S. Department of Justice, which alleges that the Swiss drugmaker gave pharmacies discounts and rebates to boost sales of two drugs, a federal judge ruled Thursday.
The FDA said today Zydus Cadila has recalled 10,200 bottles of its allergy drug promethazine hydrochloride after a high blood pressure medication was discovered in one of its bottles.
Boehringer Ingelheim has agreed to pay $650 million to wrap up thousands of lawsuits claiming Pradaxa, an anticoagulant, caused serious--even fatal--bleeding in some patients. The deal comes just weeks after the FDA completed a safety review of the drug, concluding that it was as safe as the older drug it seeks to replace, warfarin.
With the list of generic drugmakers in the FDA's bad books growing longer by the week, how to improve evaluation of its drugs was a top priority when the agency recently compiled its regulatory science goals.
California has decided to lay the responsibility for opioid overdoses, and even a resurgence in heroin use, at the feet of the drugmakers, accusing them in a lawsuit of reaping huge profits while turning a large swath of people into drug addicts.