Recent FDA approvals (through December 2009) related to Zirgan, Welchol, Sculptra Aesthetic, Berinert, Crestor, Agriflu, and Byetta.
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Generic drugs approved by FDA (through December 2009): Lansoprazole 15 mg and 30 mg tablets and Perindopril erbumine tablets, 2 mg, 4 mg, and 8 mg
New indication: Telmisartan tablets (Micardis) was approved on October 19, 2009, for cardiovascular risk reduction for patients unable to take an ACE inhibitor.
Generics makers have aggressively challenged drug patents before scheduled expiration, while brand-name manufacturers have delayed generic entry through 30-month stays, citizen petitions, and deals to "authorize" generic products that are less threatening to the brand.
Evidence-based recommendations utilize an integrated approach that combines nonpharmacologic approaches (specifically patient education, exercise, and cognitive behavioral therapy) and pharmacologic approaches in the management of fibromyalgia.
Hospitalized patients with the seasonal flu who were taking statins were twice as likely to survive than those who weren't taking the drug.
Statins may have negative effects on some cardiac patients, according to a study presented at CHEST 2009.
Prediagnosis regular nonsteroidal anti-inflammatory drug (NSAID) use and prolonged duration of NSAID use were independently associated with decreased overall mortality and colorectal cancer (CRC) mortality in women with a first primary invasive CRC, according to a large cohort study.
USA600, a rare strain of drug-resistant Staphylococcus aureus is about 5 times more deadly than other strains, according to a study at Henry Ford Hospital in Detroit.
Researchers studying the association between birth defects and antibiotics use early in pregnancy-1 month before through the third month-have found a link between common drugs used to treat urinary infections with birth defects.
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FDA announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use.
Focus on 2009: A year of novel pharmacologic agents in review; Focus on travoprost; Agents in late-stage development for the treatment of gastrointestinal disorders
Agents in late-stage development for the treatment of gastrointestinal disorders
New biologic: Ustekinumab (Stelara) was approved on September 25, 2009, for the treatment of adult patients aged 18 years or older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
This article reviews the 10 newly improved or investigational agents evaluated in this year's "Focus on" column and includes an update on the regulatory status of each drug.
Patients with inflammatory bowel disease receiving thiopurines are at increased risk of developing lymphoproliferative disorder, according to a French prospective observational cohort study, which was published online in The Lancet.
An investigation into a multistate outbreak of Serratia marcescens bloodstream infections (BSIs) published in the Archives of Internal Medicine found an association between the BSIs and contamination of prefilled syringes.
New combination: Valturna was approved on September 16, 2009, for the treatment of hypertension in patients not adequately controlled on either aliskiren or angiotensin receptor blocker monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.
FDA is struggling to implement a host of new drug safety policies and programs and still meet review time frames set by the Prescription Drug User Fee program (PDUFA).
Bulletins that focus on drugs and therapeutic matters are often distributed by hospitals and other health systems that have programs for reporting adverse drug reactions.
In August 2003, the US Department of Veterans Affairs (VA) awarded a contract for prostaglandin ophthalmic agents with travoprost as the agent of choice. Although there was no national mandate to switch patients from existing therapy, many VA facilities had agreements from their local ophthalmology and optometry departments to conduct a therapeutic interchange of patients from existing prostaglandins (eg, latanoprost) to travoprost.
Recent FDA approvals (through November 2009) related to FluMist, Cervarix, Gardasil, Fluarix, Folotyn, Micardis, Twynsta, Votrient, Mirena
In a review published in The Cochrane Library, researchers determined that atovaquone-proguanil and doxycycline were well tolerated by most travelers and are less likely than mefloquine to cause adverse neuropsychiatric outcomes.
Cholesterol-lowering statin drugs do not reduce the risk of diabetes and might modestly elevate the chances of developing the condition, researchers found in a pooled analysis of trial data.
Atypical antipsychotic agents lead to a marked and rapid weight gain in children and adolescents, according to researchers at Zucker Hillside Hospital in Glen Oaks, NY and the Albert Einstein College of Medicine, NY.
Adding insulin to standard diabetes drugs results in better blood sugar control for many with type-2 diabetes, and the dose and timing of insulin received can make a big difference, British researchers report.
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