More than 50 new indications for oncology and hematology drugs and biologics were cleared by the FDA?s Office of Oncology Drug Products from 2005 to 2007.
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Treatment with ticagrelor compared with clopidogrel in patients with acute coronary syndromes significantly reduced the death rate from vascular causes, myocardial infarction (MI), or stroke, according to the Study of Platelet Inhibition and Patient Outcomes (PLATO), a multicenter, randomized, double-blind trial.
On February 22, 2010, FDA released a safety alert reminding healthcare professionals of the agency¹s ongoing concerns regarding the cardiovascular safety of rosiglitazone (Avandia, GlaxoSmithKline).
Agents in late-stage development for the treatment of diabetes mellitus.
Tocilizumab (Actemra): An interleukin-6 receptor inhibitor for the treatment of rheumatoid arthritis
New molecular entity: Tocilizumab (Actemra) was approved in January 2010, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor antagonist therapies.
Recent FDA approvals (through March 2010) related to Iprivask, VPRIV, Mirapex ER, Cayston, Menveo, Lamictal XR, Rituxan, Oleptro, Xiaflex, Norvir, Benicar, Crestor.
Venous thromboembolism (VTE) is a debilitating and potentially fatal condition, often seen in the aging population. VTE results from clot formation in the venous circulation and presents as either deep-vein thrombosis or pulmonary embolism. A population-based study estimated that at least 201,000 new cases of VTE occur in the United States annually.
Etravirine is an HIV-1 specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) that was FDA approved for treatment-experienced adult patients with HIV-1 strains resistant to an NNRTI and other antiretroviral agents. In phase 3 trials of etravirine versus placebo, both in combination with darunavir/ritonavir, a background of nucleoside/nucleotide reverse transcriptase inhibitors with or without enfuvirtide demonstrated potent antiviral activity that was sustained through 48 weeks.
The main objectives of gout therapy are to treat the acute attack, provide prophylaxis to prevent flares, and prevent complications associated with the deposition of urate crystals in tissues. Obesity, alcohol intake, and certain foods and medications can contribute to hyperuricemia and should be identified. Pharmacologic management remains the mainstay of treatment for chronic gout and acute attacks.
New molecular entity: Liraglutide (Victoza) was approved January 25, 2010 to improve blood sugar control in adults with type 2 diabetes mellitus.
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Recent FDA action (through March 2010) related to CPI-300, Ondansetron, Intravenous acetaminophen, Gabapentin enacarbil, Rifaximin, ENMD-2076, Ap301, CM-AT, Fingolimod, Nilotinib.
On February 18, 2010, FDA recommended drastic changes in the way long-acting beta2-adrenergic agonists are used in the treatment of asthma in order to limit their utilization.
Gout: Overview and newer therapeutic developments; Focus on etravirine; Agents in late-stage development for the treatment of diabetes mellitus
In the first year of a child's life, immunization with a rotavirus vaccine (Rotarix, Glaxo Smith Kline) may markedly lower incidence of severe virus gastroenteritis.
In the past decade, federal regulatory agencies have signed off on more new product approvals for treatment of so-called neglected diseases.
Currently, exenatide is the only FDA-approved GLP-1 receptor agonist and its use is limited by the need for twice-daily injections. A long-acting release formulation of exenatide is being evaluated in clinical trials to assess effects on glucose control and patient quality of life.
Postmenopausal osteoporosis is a worldwide health concern associated with significant complications including fracture, disability, and mortality. The economic burden of this disease is substantial and is expected to increase significantly as the population ages. It is becoming increasingly important to identify patients who will benefit from available and emerging therapies for the prevention and/or treatment of osteoporosis.
Approaching the ideal selective estrogen receptor modulator for prevention and treatment of postmenopausal osteoporosis; Exenatide LAR: A sustained-release formulation of exenatide for the treatment of type 2 diabetes; and Agents in late-stage development for renal diseases
Agents in late-stage development for renal disease
Recent FDA action (through February 2010) related to Ceftobiprole, Carglumic acid, Miglustat, Nebivolol, Myocet, Pirfenidone, Davunetide, BiovaxID, EpiCept, CP-4126
In less than 1 full year at the helm of FDA, Margaret (Peggy) Hamburg has worked to reposition FDA as a public health agency able to ensure the safety and quality of the nation's food supply and medical products.
Recent FDA approvals (through February 2010) related to Ampyra, Victoza, Actemra, Tropazone, Morphine sulfate oral solution, Fluzone High-Dose
After completing a review of available tiotropium bromide inhalation powder (Spiriva HandiHaler, Pfizer) data, FDA released an updated communication, stating that in the regulatory body's opinion, available data does not support an association between the use of tiotropium, a commonly prescribed daily treatment for chronic obstructive pulmonary disease, and an increased risk of stroke, heart attack, or cardiovascular death.
Therapeutic strategies involving early conventional disease-modifying antirheumatic drugs or early biologics are preferred in treating very early rheumatoid arthritis, but the additional costs of early biologics may not be justified for all patients, according to a recent study reported in the Annals of Internal Medicine.
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