Formulary Watch |

FDA approves once-monthly aripiprazole for schizophrenia

FDA has approved aripiprazole (Abilify Maintena, Otsuka and Lundbeck) for extended-release injectable suspension for the treatment of schizophrenia.

Interim results evaluate virologic response rates in HCV/HIV co-infected patients treated with faldaprevir

The first interim results in HCV/HIV co-infected patients from Boehringer Ingelheim’s ongoing hepatitis C (HCV) clinical trial program, HCVerso, have become available. These results, from the phase 3 trial STARTVerso 4, were presented recently at the 20th annual Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.

CDC warns health departments about need for CRE prevention

The Centers for Disease Control and Prevention (CDC) reported that carbapenem-resistant enterobacteriaceae (CRE) has increased over the last decade and most cases of resistance are associated with healthcare exposures. To slow the dissemination of CRE infections, local and state health departments need to take the lead in prevention efforts, according to CDC’s Morbidity and Mortality Weekly Report released on March 5.

Colon cancer screening doubles with new EHR use

Centralized systems are likely to be the most efficient way to increase colorectal cancer screening, according to a trial published in the March 5 Annals of Internal Medicine.

FDA panel rejects menopause drug

FDA voted 2-12 against approval for an investigational, oral, twice-daily formulation of gabapentin (Sefelsa, Depomed) to treat moderate to severe vasomotor symptoms due to menopause.

FDA issues second complete response letter for Xarelto

FDA has issued a second complete response letter regarding a supplemental New Drug Application (sNDA) for rivaroxaban (Xarelto, Janssen) for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome (ACS).

Colonoscopy screening reduces risk of advanced colorectal cancer

A new study led by a researcher at the Perelman School of Medicine at the University of Pennsylvania adds support to current medical recommendations stating that screening colonoscopy substantially reduces an average-risk adult’s likelihood of being diagnosed with advanced colorectal cancer (CRC) in either the right or left side of the colon.

For season flu use antivirals regardless of vaccination status

The 2012/2013 seasonal influenza vaccine is moderately effective at preventing medically attended influenza. However, some vaccinated people may still become infected, so clinicians should use antivirals as recommended by CDC regardless of vaccination status, according to estimates published in Morbidity and Mortality Weekly Report (MMWR), February 22, 2013.

Physician dispensing costs triple that of retail

A recent study shows how much physician dispensing is costing states.

Sirturo (Bedaquiline)

New molecular entity: Late last year FDA approved bedaquiline tablets for the treatment of pulmonary multi-drug-resistant tuberculosis (MDR-TB).

Researchers seek next class of anti-allergics

Allergy season is almost upon us and anti-histamine agents remain the top choice. However, researchers are looking for new medications to help patients with different needs.

High calcium intake could raise CV mortality in women

A high calcium intake, from diet or the combination of diet and supplements may raise the rate of mortality, especially cardiovascular (CV) mortality.

Patients who adhere to statin regimens are healthier, but higher drug spending makes overall care more costly

Individuals with high cholesterol who stay on their statin medications over a 2-year period are healthier than comparable nonadherent individuals, but the overall cost of their care is slightly higher, according to a new study.

Female sexual disorders: Treatment options in the pipeline

For patients with sexual disorders, there's been very little help, but a review of the pipeline indicates that help might soon be on the way.

Pipeline Preview

Recent FDA action (through February 2013) related to, rintatolimod, insulin degludec, insulin degludec/insulin aspart, dolutegravir, Radium-223 dichloride, APG101, LG631-CD34, Placental eXpanded, buprenorphine hydrochloride, naloxone HCI dihydrate, doxorubicin hydrochloride, clindamycin in 5% dextrose, Adderall

Aspirin use linked to age-related macular degeneration

Regular use of aspirin was associated with a 2-fold greater risk of developing the neovascular subtype of age-related macular degeneration (AMD) than in non-users.

FDA Actions in Brief February 2013

Recent FDA Approvals (through February 2013) related to (Ado-trastuzumab, Kadcyla, Genentech, Everolimus, Zortress, Novartis, Adapalene, benzoyl peroxide, Epiquo, Galderma, pomalidomide, Pomalyst, Celgene, alogliptin, Nesina, Takeda Pharmaceuticals, Kazano, Oseni, imatinib, Gleevec, mesalamine, Delzicol, Warner Chilcott, mipomersen sodium, Kynamro, Genzyme, Isis Pharmaceuticals, Merck, Oxutrol for Women, glycerol phenylbutyrate, Ravicti, Hyperion Therapeutics, pneumococcal 13-valent Conjugate Vaccine, Prevnar 13, Pfizer

Low-dose contraceptive patch comparable to combination oral contraceptive in safety, tolerability study

A low-dose contraceptive patch is comparable to combination oral contraceptive in a comparative study, according to phase 3 data presented at the American College of Obstetricians and Gynecologists' (ACOG) 60th Annual Clinical Meeting.

MS specialty drug treatment costs climb to two-thirds of total MS treatment cost

Multiple sclerosis (MS) specialty drug costs no account for more than two-thirds or MS patients' total cost of care, according to a new study.

What to do about multidrug-resistant gonorrhea

Gonorrhea continues to be a major US public health problem in terms of its prevalence as week as the lack of effective treatments available.

An update in attention deficit/hyperactivity disorder

Attention-deficit/hyperactivity disorder (ADHD) is the most common neurobehavioral disorder in children. New formulations of stimulants and nonstimulants allow for individualization of therapy for patients to receive the maximum benefit while minimizing side effects.

Drug manufacturers seek payer feedback on new products

Partnering in healthcare seems to be the prevailing wind while achieving access, cost effectiveness, and high quality remains the aim of the industry.

Community-based intervention can help reduce mortality from opioid overdose

In the study of communities in Massachusetts with high numbers of opioid overdose deaths, implementation of overdose education and naloxone distribution (OEND) were associated with a significant reduction in opioid overdose death rates.

IOM report focuses on impact of counterfeit, substandard drugs

A new Institutes of Medicine (IOM) report addresses growing concerns in the global community surrounding the public safety matters of fake and substandard drugs.

Vitamin D potency varies widely in dietary supplements

The potency of vitamin D in compounded and over-the-counter (OTC) supplements varied widely, according to a recent research letter published in the February 11 issue of JAMA Internal Medicine.

CPOE system can reduce drug errors by almost half

Processing a prescription through an electronic ordering system decreases the likelihood of error on that order by 48%, and averts more than 17 million such incidents in US hospitals in 1 year alone.

New strategies needed to reduce mortality associated with cardiometabolic risk factors in young people

Among US adolescents and young adults, HbA1c levels, central obesity, and smoking were associated with an increased risk of dying before 55 years of age.

From the American College of Gastroenterology Annual Scientific Meeting: Know your options for cost-effective management of HE

The economic implications of HE are numerous and marked altered as based upon direct and indirect costs, worsening of patient's and patient's family members quality of life, employment status, and autonomy.

From the Gastrointestinal Cancers Symposium: Statins use may reduce mortality in hepatocellular cancer by 30%

Use of statins in hepatocellular carcinoma (HCC) patients may be associated with prolonged overall survival.

From the American Academy of Ophthalmology Annual Meeting: Anti-VEGF drugs: Not just for retinal pathologies alone

Use of anti-vascular endothelial growth factor (VEGF) drugs may be beneficial in patients with neovascular glaucoma and to control complications after filtration surgeries.