NME: Bendamustine (Treanda), an alkylating agent, was approved on March 20, 2008, for the treatment of chronic lymphocytic leukemia (CLL).
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Experts urged a “return to statins” after hearing the final results of the Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression (ENHANCE) trial, which demonstrated no slowing of carotid atherosclerosis progression with the addition of ezetimibe to simvastatin therapy.
Antibiotics in deveopment for the treatment of complicated skin and skin structure infections, community-acquired pneumonia, and infectious diarrhea
According to results from the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET), the angiotensin receptor blocker (ARB) telmisartan is as effective as the angiotensin-converting enzyme (ACE) inhibitor ramipril in preventing adverse cardiovascular events in high-risk patients with cardiovascular disease but without heart failure.
At a March 5, 2008, commission meeting, the Medicare Payment Advisory Commission (MedPAC) discussed the feasibility of requiring pharmaceutical companies and medical product manufacturers to report financial relationships and gifts to physicians on a national basis.
Approximately 1.7 million healthcare-associated infections (HAIs) occur in US hospitals each year. These HAIs, which include pneumonia, bloodstream infections (BSIs), and urinary tract infections (UTIs), account for approximately 99,000 deaths and $5 billion in additional healthcare costs.
Much to the surprise of most close FDA observers, Janet Woodcock, MD, agreed in March to resume control of the Center for Drug Evaluation and Research (CDER). Dr Woodcock headed CDER for 10 years before becoming deputy commissioner and, more recently, FDA’s chief medical officer. But when CDER director Steven Galson, MD, MPH, left last year, Dr Woodcock served as the temporary CDER chief. Now, after a long search for a replacement, she has decided to accept the position herself.
The Food and Drug Administration Amendments Act (FDAAA) enacted in September 2007 requires new initiatives to expand information on the risks and benefits of prescription drugs. One goal established in FDAAA is the modernization of FDA’s system for detecting adverse drug events (ADEs); therefore, the current system is being reviewed so limitations and capabilities can be identified.
Data from EPITHET presented at the International Stroke Conference 2008 demonstrates that extending the standard 3-hour window for tPA could benefit patients who suffer a stroke and have a perfusion-diffusion mismatch.
Label updates and warnings through April 2008 related to epoetin alfa and darbepoetin alfa, darunavir, and tiotropium.
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Study shows no significant differences in safety risks between off-label use of drug-eluting stents (DES) and off-label use of bare-metal stents (BMS) and a decreased risk of repeat PCI with use of off-label BMS.
How-to guide for creating drug monographs and drug class reviews for evidence-based formulary consideration.
Treatment of diabetes with DPP-IV inhibitors; sitagliptin, vildagliptin, alogliptin, and saxagliptin.
Generic drugs approved by FDA (through April 2008) including cefuroxime for oral suspension, pramipexole tablets, alendronate once-daily tablets, and alendronate once-weekly tablets.
Recent FDA approvals and indications (through April 2008) related to Xyntha, Simcor, Aloxl, Humira, Abilify, Avastin, Nexium, and Luvox.
Recent FDA action (through April 2008) related to Rotavirus vaccine, live, oral; istradefylline; olanzapine long-acting injection; mycobacterial cell wall-DNA complex; talactoferrin; levodopa/carbidopa intestinal gel; prasugrel; eltrombopag; difluprednate ophthalmic emulsion; EUR-1008; ARG201; MGCD0103; triphendiol; ADH-1; and levofloxacin solution for inhalation.
New biologic: Rilonacept (Arcalyst), a regeneron Interleukin-1 blocker was recently approved for the treatment of cryopyrin-associated periodic syndromes (CAPS).
NME: Desvenlafaxine (Pristiq), a selective serotonin and norepinephrine reuptake inhibitor was recently approved for the treatment of major depressive disorder.
Drugs in development for the treatment of Huntington disease, Parkinson disease, and amyotrophic lateral sclerosis
Bevacizumab plus paclitaxel can slow breast cancer progression but does not improve overall survival
Adding bevacizumab to treatment with paclitaxel does not prolong overall survival among patients with metastatic breast cancer; however, the combination therapy is associated with a significant improvement in progression-free survival, according to the results of a trial published in the New England Journal of Medicine (NEJM).
This article discusses pharmacologic options for the treatment of Crohn's disease, including aminosalicylates, corticosteroids, immunosuppresant agents, and biologic agents.
First-time generic approval: Balsalazide capsules
A summary of drugs and indications recently approved by FDA: Intelence, Alvesco Inhalation Aerosol, Moxatag, Humira, Asmanex, Tekturna HCT, Herceptin
FDA-related information through March 2008 on C1 inhibitor, ferric carboxymaltose injection, lovastatin, carbidopa/levodopa extended release, vigabatrin, bortezomib, peginterferon alfa-2b, elesclomol, triphendiol, VQD-002
Colesevelam (Welchol) was approved on January 18, 2008, as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.
Labeling changes and safety information regarding Botox, selected antiepileptic drugs, Chantix, and Ortho Evra (through March 2008)
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