Latest Fda Approved Drugs Information Systems

September 19, 2012 Drug Name Active Ingredient Dosage Form/Route Sponsor Submission Type Doxil doxorubicin hydrochloride Injectable, Liposomal; Injection Janssen R and D Labeling Revision Prevacid 24 Hr lansoprazole Capsule, Delayed Rel Pellets; Oral Novartis Labeling Revision

On September 24, 2012, the U.S. Food and Drug Administration announced the formation of an internal task force that will support the development of new antibacterial drugs, a critical public health care goal and a priority for the agency. As part of its work, the Antibacterial Drug Development Task Force will assist in developing and revising guidance related to antibacterial drug development, as required by the Generating Antibiotic Incentives Now (GAIN) Title of the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012.  Research and development for new antibacterial drugs has been in decline in recent decades, and the number of new FDA-approved antibacterial drugs has been falling steadily since the 1980s. During this time, the persistent and sometimes indiscriminate use of existing antibacterial drugs worldwide has resulted in a decrease in the effectiveness of these drugs. This phenomenon, known as antibacterial drug resistance...

Patients with sepsis or septic shock admitted to European intensive care units (ICUs) were more severely ill and had a 10% higher raw mortality rate compared with patients admitted to US ICUs, according to results from a comparison study  published online October 26 in the  Lancet Infectious Diseases . After adjusting for organ dysfunction and severity of illness, however, the mortality rates were comparable. Mitchell M. Levy, MD, from the Division of Pulmonary and Critical Care Medicine, Warren Alpert Medical School of Brown University, Providence, Rhode Island, and international colleagues analyzed the records of 25,375 patients in US (18,766 patients) and European (6609 patients) hospitals who were admitted to 107 US hospital ICUs and 79 ICUs in Europe between January 2005 and January 2010. Their primary goal was to assess whether hospitals were complying with international, evidence-based guidelines for resuscitation and management under the Surviving Sepsis Campaig...

Among almost 30,000 Medicare beneficiaries treated for early-stage breast cancer, the complication rate was 17% higher with breast brachytherapy than with whole-breast irradiation (WBI), according to a study  published online  October 22 in the  Journal of Clinical Oncology . This casts some doubt on the widespread use of breast brachytherapy. Although WBI has been the standard of care for 20 years, "currently there are no large randomized controlled trials or population-based studies confirming brachytherapy as a safe and effective alternative to WBI," study author Carolyn Presley, MD, from Yale University School of Medicine in New Haven, Connecticut, and colleagues write. "Given the higher costs associated with brachytherapy, the higher risk of complications suggests that clinicians, patients, and policy makers should scrutinize the use of this treatment modality," they note. This suggestion has drawn criticism from a European expert who says the brachy...

The European Medicines Agency (EMA) may soon elevate the importance of quality-of-life (QoL) outcomes in the assessment of new cancer therapies. The EMA is creating a QoL appendix that will likely be added to its standard guideline for evaluating and approving cancer drugs and therapies, according to press materials. Thus, treatment-related fatigue, nausea, sexual dysfunction, psychological problems, and other factors will become more important than they have been in terms of a therapy's approval. This impending development was the subject of a session at the 3rd European Organization for Treatment and Research in Cancer (EORTC) conference, entitled International Quality of Life and Clinical Trials Conference, held in Brussels, Belgium. "There is increasing recognition that health-related QoL is an effective and relevant measure with which to evaluate and monitor therapeutic outcomes. Health-related QoL measures may complement the range of traditional objective indi...

MIAMI   — New results from the  PARTNER B  trial of the Edwards Lifesciences  Sapien  transcatheter aortic valve in inoperable patients shows that the mortality benefit of the device persists at least three years and that the survival prognosis in patients undergoing transcatheter aortic-valve implantation (TAVI) correlates to the severity of their comorbidities at the time of implant [1,2]. Here at  TCT 2012 ,  Dr E Murat Tuzcu  (Cleveland Clinic, OH) presented the three-year follow-up data from PARTNER B showing that all of the major benefits of TAVI vs standard therapy shown at a previous time point--measured by all-cause mortality, cardiovascular mortality, repeat hospitalization, and functional status--are sustained out to three years. As reported by  heart wire   ,  PARTNER B compared Sapien with standard care in patients who were too ill to withstand surgery. PARTNER B initially randomized 179 patients to TAVI with Sap...

MIAMI — Everyone agrees: the  Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment   (RESPECT) and  PC Trial   both missed their primary end point, and that's probably where the consensus ends. The two trials had assessed whether a patent foramen ovale (PFO) closure device could reduce the risk of recurrent stroke in patients who had experienced cryptogenic stroke. Results were presented today at  TCT 2012 . As both studies were negative, one clearly so and the other with a benefit when evaluating the "as-treated" patients only, researchers and clinicians were left to interpret the results in light of positive secondary end points and past observational reports suggesting a possible benefit of closing PFOs in these patients. One believes the PC and RESPECT results shouldn't change clinical practice, while another was more generous and said that while the study results weren't a "home run,"...

AURORA, Colorado — US researchers say much more work is needed to improve rates of bystander cardiopulmonary resuscitation (CPR) for an out-of-hospital cardiac arrest, as their new data show that the likelihood of a person receiving CPR depends on the median income and the racial composition of their neighborhood [1]. Dr Comilla   Sasson  (University of Colorado School of Medicine, Aurora) and colleagues analyzed surveillance data from 29 American cities and report their findings in the October 25, 2012 issue of the  New England Journal of Medicine . "The odds of receiving bystander-initiated CPR were approximately 50% lower in low-income black neighborhoods than in high-income nonblack neighborhoods," Sasson told  heart wire   . And even in high-income black neighborhoods, patients with out-of-hospital cardiac arrest "were approximately 23% less likely to receive bystander-initiated CPR than were patients in high-income nonblack neighborhoods.   W...

A 16-month US Senate Committee on Finance investigation into Medtronic, the maker of  InFuse , a recombinant bone morphogenic protein-2 (rhBMP-2) product used in spinal fusion surgery, has found "questionable ties" between that company and physician consultants who tested and reviewed its products. In a report released yesterday, the Finance Committee, which has sole jurisdiction over Medicare and Medicaid, determined that without public disclosure of their roles, Medtronic employees collaborated with physician authors to edit, and in some cases, write, segments of published studies on rhBMP-2. The studies as published may have inaccurately represented the product's risks and may have placed added weight on adverse effects of alternative treatments, according to a press release issued by the Committee. Medtronic also maintained significant, previously undisclosed financial ties with physicians who authored studies about the product, making $210 million in payments ...

Clinicians should consider performing lumbar puncture in asymptomatic patients who received epidural or paraspinal injections with contaminated steroid products linked to the ongoing and widening fungal meningitis outbreak, officials with the Centers for Disease Control and Prevention (CDC) said today during a Clinician Outreach and Community Action (COCA) call. As of today, there are 328 cases of fungal infection and 24 deaths in 18 states linked to injectable methylprednisolone acetate produced by the New England Compounding Center (NECC) in Framingham, Massachusetts. This includes 5 peripheral joint infections. Since early in the outbreak, the CDC has recommended against antifungal prophylactic or presumptive treatment of exposed asymptomatic patients in the absence of diagnostic testing with results indicating meningitis. This recommendation "remains unchanged," Tom Chiller, MD, MPH, medical epidemiologist in the Division of Foodborne, Waterborne & Environmenta...