On Wednesday, the US Food and Drug Administration (FDA) released the text of a new Untitled Letter sent to Johnson & Johnson - the second sent in as many months to the same company - regarding promotional material for its blockbuster anticoagulant Xarelto (rivaroxaban), alleging that the company failed to present the risks of the drug in a fair and balanced manner. Background: Doxil Untitled Letters are less serious than the more widely-known Warning Letters, whic...

Is there something inherently wrong with most currently-marketed blood glucose meters? Some healthcare industry watchers may be thinking that today, as yet another company has issued a voluntary recall for all its blood glucose meter devices, citing the same core defect that led to last month's recall of a similar product manufactured by Johnson & Johnson. Background On 25 March 2013, Lifescan, a subsidiary of Johnson and Johnson, issued a recall of nearly 2 million...

US regulatory officials have announced the approval of Johnson & Johnson's new type 2 diabetes product, Invokana (canaglifilozin)-the first sodium-glucose co-transporter 2 (SGLT2) inhibitor approved by the agency. "Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors," said Mary Parks, director of the Division of Metabolism and Endocrinology Products (DMEP)at FDA's Center for Drug Evalua...

The US Food and Drug Administration's (FDA) Office of Generic Drugs (OGD), part of its Center for Drug Evaluation and Research (CDER), is out with the new policy that aims to clarify how its staff should implement a relatively new statutory provision that permits the agency to approve generic drugs even when labeling changes are happening with  its comparator product, the reference listed drug (RLD). Background The section in question, 505(j)(10) of the Federal Fo...

The US Food and Drug Administration (FDA) has received approval from a federal judge for a consent decree of permanent injunction between it and Ben Venue Laboratories, a manufacturing facility long in the crosshairs of the agency's enforcement officials. Background The company, a subsidiary of Boehringer Ingelheim, suspended its manufacturing capabilities in 2011 after receiving a string of warning letters from FDA over the maintenance of its current good manufacturing...

At the beginning of 2012, The New York Times made something of a sensational claim: Johnson & Johnson had worked to privately phase out its now-controversial metal-on-metal hip implants in 2009 after US regulators approached the company with concerns about their durability and patient safety. In response to that report, the company indicated that the two events were "unrelated," but now new and potentially troubling information is emerging from a Los Angeles cou...

Japan's Pharmaceutical and Medical Device Agency (PMDA) has launched J-MACS (Japanese Registry for Mechanically Assisted Circulatory Support), a data-collection project on the post-marketing experience with ventricular assist devices (VAD). The system, said regulators, is intended to be the first step in developing a new national system for collecting and evaluating data on the post-marketing experience with implantable medical devices. The project is a collaborative ...

The US Food and Drug Administration (FDA) plans to continue to allow a substitute for the anti-cancer drug Doxil, manufactured by Johnson & Johnson subsidiary Ben Venue Laboratories, into the country in the near future despite Ben Venue's 17 October announcement that it has resumed production at its Bedford, Ohio facility. Ben Venue suspended the majority of manufacturing activities at its Bedford plant in November 2011 after inspectors from FDA identified a series o...

A long-running drug shortage involving Johnson & Johnson's anti-cancer drug Doxil (doxorubicin) may be on the verge of easing after the company applied to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for approval of a new, shared manufacturing method. The root of Doxil's shortages is a " voluntary shutdown " of an Ohio facility run by Ben Venue Laboratories, a contract manufacturer working for J&J, after a November 2011 i...

Even after stepping down from his position as head of the US Food and Drug Administration (FDA), former Commissioner David Kessler seems to be having a strong impact on the fortunes of some pharmaceutical companies. Kessler had been called on to testify on behalf of litigants in a series of trials set to be heard in a Pennsylvania court room the week of 8 October regarding Johnson & Johnson's marketing of its antipsychotic drug Risperdal (risperidone). Litigants have...

Johnson and Johnson will pay $181 million to settle a lawsuit about how it marketed an antipsychotic drug, but the company denies any wrongdoing, according to a PMLive report. The suit claims the drug, Risperdal, was promoted for uses not approved by the U.S. Food and Drug Administration and also made false claims about its effects. The payment will be distributed to 36 states and the District of Columbia, the report said. This is the latest round of problems J&J ha...

Abbreviated new drug applications-also known as generic drug applications or 505(j) applications-have saved US citizens more than a trillion dollars in the past decade, says a new report out from the health data analytics firm IMS Health and sponsored by the Generic Pharmaceutical Association (GPhA). The report, " Savings: $1 Trillion Over 10 Years ," comes as healthcare costs continue to rise, outpacing inflation on a consistent basis. Generic medicines, says the repo...