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The FDA has slapped a warning on an Italian active pharmaceutical ingredient manufacturer for deleting quality data, the latest indication the agency is serious about clamping down on poor manufacturing data integrity. Read More
Hospira conducted its fourth recall in roughly two months due to contaminated products, leading to another quality headache for the injectables giant. Read More
The FDA this week approved the first human recombinant C1-esterase inhibitor product for adolescents and adults with acute attacks of a rare condition called hereditary angioedema (HAE). 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
A group of third-party pharmaceutical payers is moving to settle part of a class action lawsuit against Pfizer-subsidiary King Pharmaceuticals and generics maker Mutual Pharmaceutical over their alleged collusion to delay a generic of the muscle relaxant Skelaxin. Read More
Mylan has further cemented its win in a breach-of-contract lawsuit against GlaxoSmithKline with a court order prohibiting GSK from providing an authorized generic version of the antidepressant Paxil to Mylan’s competitor Apotex. Read More
The FDA admonished Concordia Pharmaceuticals for a telephone sales pitch about its attention deficit hyperactivity disorder drug Kapvay that omits critical risk and dosing information. Read More
Starting next year, drugmakers in Canada will need to submit for premarket review information on proposed drug names, labels and packages under amended regulations that aim to ensure drug labeling is clear and easy to understand and a drug can’t be confused with another product. Read More
The Indian government is offering a reward to whistleblowers who provide information leading to the seizure of spurious, adulterated and misbranded drugs. 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