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The FDA intends to step up its scrutiny of a company’s data integrity protections during manufacturing inspections, following a series of investigations that caught drugmakers backdating manufacturing records and falsifying data. Read More
Pfizer is facing at least three class action lawsuits alleging that the company went to extraordinary, fraudulent lengths to maintain exclusivity over its multibillion dollar arthritis pain drug Celebrex and keep generic competitors off the market. Read More
Indian generics maker Sun Pharmaceutical is voluntarily recalling 41,127 bottles of the antidepressant venlafaxine HCl extended-release tablets over improper dissolution. Read More
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