Drug Safety

Latest Headlines

Latest Headlines

Ranbaxy decision shows why FDA reluctant to rely on European inspections

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.

Vietnam bans products from 45 Indian companies for failing to meet standards

Regulators in Vietnam have banned drug imports from dozens of companies, saying they are substandard.

FDA approves first nasally delivered gel for 'Low T'

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.

Chicago sues J&J, Purdue, Endo, Actavis, Teva over opioid marketing

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.

Zydus recall flags another costly bottle mixup

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.

District judge green-lights kickback lawsuit against Novartis

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.

Zydus Cadila bottling flop sparks another Indian recall

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 to pay $650M to wrap up thousands of Pradaxa lawsuits

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.

FDA puts improved generic evaluations on $50M regulatory wishlist

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 goes after Purdue, Endo, J&J, Actavis and Teva over opioids

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.