Formulary Watch |

Drug development and regulation could be affected by limited resources at FDA

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

First-time generic drug approval, February 2008

First-time generic approval: Granisetron injection

FDA actions in brief, February 2008

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

Ceftobiprole: The first anti-MRSA cephalosporin antibiotic

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.

A review of nonpharmacologic and pharmacologic therapies for smoking cessation

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

Natalizumab (Tysabri): Monoclonal antibody approved for the treatment of moderate-to-severe Crohn's disease

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 Pipeline Preview, February 2008

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

Nebivolol (Bystolic): Beta-blocker approved for the treatment of hypertension

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

January enews art

Sapropterin (Kuvan): Synthetic form of tetrahydrobiopterin approved for the treatment of PKU

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

Equivalent dosing of irbesartan, valsartan, and losartan identified through formulary switch at a Veterans Affairs medical center

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.

Drug Watch: Agents in late-stage development for the treatment of dermatologic disorders (January 2008) (PDF)

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

Bar coding helps improve patient safety

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

December 2007 Safety labeling updates & new warnings: rosiglitazone, erythropoiesis-stimulating agents, aprotinin

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.

Certolizumab pegol: A pegylated anti-TNF-alpha antibody fragment for the treatment of Crohn's disease

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.

January 2008 Safety labeling updates & new warnings: mycophenolic acid (Myfortic), varenicline (Chantix), and desmopressin

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

Biologic treatment of RA associated with increased risk of nonmelanotic skin cancer and melanoma

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 actions in brief, January 2008

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 approval, January 2008

First-time generic approvals: oxycodone/ibuprofen

Pipeline Preview, January 2008

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

Methoxy polyethylene glycol-epoetin beta (Mircera): ESA approved for the treatment of anemia in patients with chronic renal failure

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.

Sapropterin (Kuvan): Synthetic form of tetrahydrobiopterin approved for the treatment of PKU

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

December Artwork

artwork

Drug Watch: Agents in late-stage development for the prevention and/or treatment of osteoporosis (December 2007) (PDF)

A summary of agents in late-stage development for the prevention and/or treatment of osteoporosis.

Increased need for pacemaker insertion demonstrated among women treated with amiodarone for AF

According to the results of a prospective cohort study of 1,005 patients with new-onset atrial fibrillation (AF), women who are treated with amiodarone are at greater risk for bradyarrhythmia requiring pacemaker insertion than men who are treated with the drug.

First-time generic approvals, December 2007

First-time generic approvals: rivastigmine capsules

Clinical news updates from the 2007 AHA Scientific Sessions

The 2007 American Heart Association (AHA) Scientific Sessions took place November 3 to 7, 2007, in Orlando, Florida. Among the new data presented were the much anticipated results of a phase 3 trial of prasugrel versus clopidogrel in patients scheduled for percutaneous coronary intervention (PCI). Other clinical trials of note were the first prospective study of a statin in patients with ischemic heart disease and heart failure and a comparison of eptifibatide with abciximab on ST-segment resolution in patients with myocardial infarction (MI) who are undergoing primary PCI. This AHA Special Report details these and other trials.

Incidence of ADEs in patients readmitted within 30 days of discharge in a tertiary care teaching hospital

Anecdotal reports of hospital readmissions secondary to adverse drug events (ADEs) prompted the pharmacy & therapeutics (P&T) committee at University Hospital, SUNY Upstate Medical University, to authorize a pharmacy-led retrospective review of patient records.

Doripenem: A new extended-spectrum carbapenem antibiotic

Doripenem is a carbapenem antibiotic recently approved for the treatment of complicated intra-abdominal infections (IAIs) and complicated urinary tract infections (UTIs), including pyelonephritis. An NDA has also been submitted for the use of doripenem in the treatment of nosocomial pneumonia, including ventilator-associated pneumonia (VAP). Doripenem is the fourth carbapenem approved for use in the United States and exhibits many pharmacologic similarities with imipenem/cilastatin and meropenem. Doripenem has a broad spectrum of activity against various gram-positive and gram-negative aerobic and anaerobic bacteria, including many multidrug-resistant gram-negative pathogens. Improved potency against nonfermentative gram-negative bacteria has also been demonstrated with doripenem compared with other carbapenems. In clinical trials, doripenem was generally well tolerated; headache, nausea, diarrhea, and phlebitis were the most commonly reported drug-related adverse events. Because doripenem exhibits..

December 2007 Safety labeling updates & new warnings: rosiglitazone, erythropoiesis-stimulating agents, aprotinin

Labeling updates and warnings related to rosiglitazone, erythropoiesis-stimulating agents, and aprotinin (December 2007)