Drug Pipeline

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.

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.

Recent FDA approvals (through October 2009) related to Sabril, Helixate FS, Valcyte, Metozolv ODT, Xyzal, Zevalin, Extavia, Astepro, Zenpep, and Bepreve

FDA officials are taking steps to erase the charges of incompetency and ineffectiveness that have plagued the agency for several years.

New combination: Morphine/naltrexone extended-release capsules (Embeda) were approved on August 13, 2009, for the management of moderate-to-severe pain when continuous analgesia is needed for an extended time period

Recent FDA action (through October 2009) related to doxorubicin, trabectedin, carisbamate, alogliptin/pioglitazone, HPV vaccine, pralatrexate, romidepsin, hyaluronic acid, laromustine, clofarabine, prGCD, KNS-760704, rifaximin, hexvix, and quinazoline495

Generic drugs approved by FDA (through October 2009): 1% clindamycin/5% benzoyl peroxide gel, triamcinolone acetonide nasal spray, clonidine transdermal system, betamethasone acetate and betamathasone sodium phosphate injectable suspension

New formulation: Guanfacine extended-release tablets (Intuniv) were approved on September 2, 2009, for the treatment of attention-deficit/hyperactivity disorder (ADHD)

New molecular entity: Telavancin for injection (Vibativ) was approved on September 11, 2009, for the treatment of complicated skin and skin-structure infections (cSSSIs)

Fampridine-SR is a sustained-release oral medication that is pending FDA approval for the symptomatic treatment of multiple sclerosis (MS).

Specialty pharmacies are uniquely positioned to play a key role in the implementation of Risk Evaluation and Mitigation Strategies (REMS).

In an update to an earlier communication, FDA announced that the manufacturers of the leukotriene inhibitors montelukast (Singular), zafirlukast (Accolate), zileuton (Zyflo), and zileuton extended-release (Zyflo CR) are adding information about neuropsychiatric events to product labeling.

Pharmacists can improve patient outcomes by following 3 major functions: identification of potential and actual medication-related problems (MRPs), resolution of actual MRPs, and prevention of potential MRPs. The best way to achieve these goals is through accurate documentation, and one of the chief obstacles to this is time?or rather the lack of it. Various software programs have been developed to help pharmacists reduce time spent identifying opportunities for interventions.

Even before the emergence of the swine flu pandemic, biopharmaceutical companies were investing in vaccines and treatments for lethal diseases that plague much of the world. There is growing recognition that Americans and Europeans are vulnerable to infections from overseas, and that development of new medications is critical to ensuring public health.