Formulary Watch

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)

Etravirine is a second-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) that was approved January 18, 2008, for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to NNRTIs and other antiretroviral agents.

A review of agents in late-stage development as of March 2008 for the treatment of diabetic retinopathy, dry eye syndrome, macular degeneration, and diabetic macular edema

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The use of rosiglitazone to treat type 2 diabetes in older patients has been associated with an increased risk of cardiovascular events.

In 2 studies, lenalidomide plus dexamethasone has been demonstrated to be an effective therapy for relapsed and/or refractory multiple myeloma.

Report by FDA's Science Board cites a need for updates to the agency's information infrastructure and research programs to avoid significant problems.

A summary of drugs and indications recently approved by FDA: Cialis, Evicel, Voluven, Thyrogen, Diovan, Cymbalta, Triesence, Vyvanse, Glumetza, Sular

Ceftobiprole is the first anti-MRSA cephalosporin antibiotic to be sumbitted to FDA for approval. If approved, the drug will likely be considered a second-line antibiotic for the treatment of cSSSIs.

This article provides information about pharmacologic and nonpharmacologic treatments that are used to help people stop smoking, including the use of varenicline.

FDA-related information through February 2008 on Fluvoxamine extended-release capsules, dalbavancin, bazedoxifene, HPV vaccine (Cervarix), valrubicin, motexafin gadolinium, COL-003, CDX-110, sugammadex, mecaserim rinfabate, A-001, beclomethasone, clobazam, fludarabine tablets, JZP-8, and AST-120

FDA-related information through February 2008 on Fluvoxamine extended-release capsules, dalbavancin, bazedoxifene, HPV vaccine (Cervarix), valrubicin, motexafin gadolinium, COL-003, CDX-110, sugammadex, mecaserim rinfabate, A-001, beclomethasone, clobazam, fludarabine tablets, JZP-8, and AST-120

FDA approved nebivolol on December 17, 2007, as monotherapy or in combination with other antihypertensive agents for the treatment of hypertension.

FDA approved sapropterin on December 13, 2007, to reduce blood Phe levels in patients with hyperphenylalaninemia (HPA) due ro BH4-responsive phenylketonuria (PKU).

Until 2005, irbesartan was the only ARB available on the Veterans Affairs (VA) healthcare system's national formulary. In 2005, irbesartan was removed from the formulary and was replaced with valsartan and losartan. For those patients who were to continue ARB therapy via a switch to either losartan or valsartan, dosing guidelines were created by the Veterans Integrated System Network 7 to facilitate the change. These guidelines suggested that patients taking irbesartan 150 mg once daily be treated with either valsartan 80 mg or losartan 50 mg once daily and that patients taking irbesartan 300 mg once daily be treated with either valsartan 160 mg or losartan 100 mg once daily. To determine if the dosing guidelines resulted in equal antihypertensive effectiveness, we carried out a retrospective chart review, examining the cases of 86 patients at the William Jennings Bryan Dorn VA Medical Center in Columbia, South Carolina, who had switched from irbesartan to either losartan or valsartan.

Drugs in development as of January 2008 for the treatment of actinic keratosis, melanoma, andpsoriasis

Bar coding drugs has been demonstrated to improve patient safety by reducing medication errors.

Patients with glucocorticoid-induced osteoporosis who are at high risk for fracture may experience greater increases in bone mineral density (BMD) with teriparatide than with alendronate, according to an 18-month, international, randomized, double-blind, controlled trial that included 428 patients.

Two tumor necrosis factor-alpha (TNF-alpha) inhibitors, infliximab and adalimumab, are approved by FDA for the treatment of moderate-to-severe Crohn's disease (CD) in patients who have an inadequate response to conventional therapies. Certolizumab is a pegylated TNF-alpha inhibitor being investigated for the treatment of moderate-to-severe CD.

Labeling updates and warnings through January 2008 for mycophenolic acid (Myfortic), varenicline (Chantix), and desmopressin

The use of biologic treatment for rheumatoid arthritis (RA) is associated with an increased risk of nonmelanotic skin cancer and melanoma, according to a large observational study published that included 13,001 patients.

FDA-related information through January 2008 for sorafenib (Nexavar), aripiprazole (Abilify), rosuvastatin (Crestor), irbesartan/hydrochlorothiazide (Avalide), extended-release quetiapine (Seroquel XL), delayed-release oral suspension of pantoprazole (Protonix), lopinavir/ritonavir (Kaletra), and dasatinib (Sprycel)

First-time generic approvals: oxycodone/ibuprofen

FDA-related information through January 2008 on Extended-release ropinirole (Requip XL); Indiplon; Xience V Everolimus Eluting Coronary Stent System; tetrabenazine; vernakalant (Kynapid); gepirone extended-release; lovastatin (Mevacor); bevacizumab (Avastin); tedisamil; rabies monoclonal antibody cocktail; AVI-4658; alfimeprase; Prochymal; aripiprazole (Abilify); bendamustine (Treanda); ATIR; CDX-110; and ISIS 333611

FDA approved methoxy polyethylene glycol-epoetin beta on November 14, 2007, for the treatment of anemia associated with chronic renal failure in adults, including those undergoing dialysis and those not undergoing dialysis.