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Pfizer will pay $35 million divided among 41 states and the District of Columbia to settle allegations it improperly marketed its immunosuppressant Rapamune for unapproved uses, a year after making a $490.9 million deal with the federal government for similar allegations. Read More
British regulators are seeking industry input to create a “white list” of prescription drugs that should be exempt from an EU requirement to verify the authenticity of products, as well as a “black list” of nonprescription drugs that must bear the verification. Read More
The European Medicines Agency wants to bring its policy on accessing drug safety reports in line with pharmacovigilance legislation, which aims to simplify reporting and increase data sharing among international organizations. Read More
Actavis initiated a consumer-level recall of its amoxicillin powder for oral suspension in New Zealand after pharmacists found glass particles in two bottles of the liquid antibiotic. Read More
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More
Drugs launched after Congress passed legislation to accelerate the approval process are more likely to be given safety warnings or pulled from the market altogether, according to a new study critical of the FDA’s current review process. Read More
Actavis initiated a consumer-level recall of its amoxicillin powder for oral suspension in New Zealand after pharmacists found glass particles in two bottles of the liquid antibiotic. Read More
German manufacturer Fresenius Kabi’s U.S. subsidiary is recalling nearly 3 million vials of an injectable anti-seizure medication due to glass flakes in sample vials. Read More
Injectables giant Hospira has initiated its second nationwide recall in as many months due to a glass supplier issue that resulted in the presence of particulates. Read More
After asking drugmakers in 2011 to voluntarily withdraw pain medications containing more than 325 milligrams of acetaminophen over safety issues, the FDA has pulled the remaining ANDAs from firms that either failed to submit sufficient data with their withdrawal applications or didn’t submit an application at all. Read More
Iowa’s Supreme Court has once again confirmed that brand manufacturers can’t be held liable for injuries sustained when patients take a generic version of their drug. But the ruling also left generics makers slightly more liable to product injuries than in most recent “failure-to-warn” cases. Read More