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First-time generic approvals, December 2009

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

Telmisartan (Micardis): Angiotensin II receptor blocker tablets approved for cardiovascular risk reduction for patients unable to take an ACE inhibitor

New indication: Telmisartan tablets (Micardis) was approved on October 19, 2009, for cardiovascular risk reduction for patients unable to take an ACE inhibitor.

Generic drugs dominate market, look to expand into biologics

Fibromyalgia: A review of management options

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.

Statins improve H1N1 survival

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 effect on some cardiac patients

Statins may have negative effects on some cardiac patients, according to a study presented at CHEST 2009.

NSAIDs reduce mortality in colorectal cancer

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.

Rare strain of S. Aureus is found to be the deadliest

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.

Some antibiotics tied to birth defects

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.

FDA initiative announced to reduce preventable harm from medication

FDA announced the Safe Use Initiative, a program aimed at reducing the likelihood of preventable harm from medication use.

Formulary Digital Edition November 2009

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

Drug Watch: Agents in late-stage development for the treatment of gastrointestinal disorders (November 2009) (PDF)

Agents in late-stage development for the treatment of gastrointestinal disorders

Ustekinumab (Stelara): First-in-class human monoclonal antibody approved for treatment of moderate-to-severe plaque psoriasis

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.

Focus on 2009: A year of novel pharmacologic agents in review

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.

Thiopurines increase lymphoproliferative disorder risk in IBD patients

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.

Bloodstream infections and contaminated prefilled syringes: issues of medication safety

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.

Valsartan and aliskiren (Valturna): Combination of an angiotensin receptor blocker with direct renin inhibitor approved for the treatment of hypertension

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.

Safety concerns slow new drug review and approval processes

Development of an adverse drug reaction bulletin in a teaching hospital

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.

Travoprost: A prostaglandin analogue for the treatment of glaucoma

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.

FDA actions in brief, November 2009 (FluMist, Cervarix, Gardasil, Fluarix, Folotyn, Micardis, Twynsta, Votrient, Mirena)

Recent FDA approvals (through November 2009) related to FluMist, Cervarix, Gardasil, Fluarix, Folotyn, Micardis, Twynsta, Votrient, Mirena

Two antimalaria drugs are tolerated regimens in regions with resistance

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.

Statin drugs may increase diabetes risk

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.

New antipsychotics lead to weight gain in young patients

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.

Long-acting, once-a-day insulin dose may be best for type 2 diabetics

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.

Study results show risk factors for ulcer development among NSAID users

Horizon Therapeutics Inc., a privately held biopharmaceutical company, recently presented an analysis from 2 pivotal phase 3 trials (REDUCE-1 and REDUCE-2) evaluating its lead investigational compound HZT-501, a combination of ibuprofen with high-dose famotidine, PRNewswire reports.

Three diet drugs in final stages of research and development

Three prescription diet drugs are in the final stages of development. According to USA Today, the drugs' manufacturers still have to submit their new drug applications to FDA and go through a rigorous review and approval process.

Comparative effectiveness research could threaten personalized medicine, NIH director warns

The federal government?s push to control health costs through comparative effectiveness research could threaten strides in personalized medicine, in which medicines are tailored to an individual?s genetic makeup, said the National Institutes of Health chief at a recent forum sponsored by the American Association for the Advancement of Science.

Formulary Digital Edition October 2009

Specialty pharmacy's role in REMS, FDA's new drug safety program; Focus on Fampridine-SR; FDA leadership promotes scientific integrity, quality standards

Drug Watch: Agents in late-stage development for the treatment of atherosclerosis and hypertension (October 2009) (PDF)

Agents in late-stage development for the treatment of mixed dyslipidemia, coronary heart disease, atherosclerosis, and hypertension