Formulary Watch |

FDA imposes new safety requirements to curb use of LABAs in asthma patients

On February 18, 2010, FDA recommended drastic changes in the way long-acting beta2-adrenergic agonists are used in the treatment of asthma in order to limit their utilization.

Formulary Digital Edition March 2010

Gout: Overview and newer therapeutic developments; Focus on etravirine; Agents in late-stage development for the treatment of diabetes mellitus

2010 Rate Card

2010 Media Kit

Rotavirus vaccination may lessen occurrence of gastroenteritis in small children

In the first year of a child's life, immunization with a rotavirus vaccine (Rotarix, Glaxo Smith Kline) may markedly lower incidence of severe virus gastroenteritis.

Drugs for orphan diseases seeing more FDA approvals

In the past decade, federal regulatory agencies have signed off on more new product approvals for treatment of so-called neglected diseases.

Exenatide LAR: A sustained-release formulation of exenatide for the treatment of type 2 diabetes

Currently, exenatide is the only FDA-approved GLP-1 receptor agonist and its use is limited by the need for twice-daily injections. A long-acting release formulation of exenatide is being evaluated in clinical trials to assess effects on glucose control and patient quality of life.

Approaching the ideal selective estrogen receptor modulator for prevention and treatment of postmenopausal osteoporosis

Postmenopausal osteoporosis is a worldwide health concern associated with significant complications including fracture, disability, and mortality. The economic burden of this disease is substantial and is expected to increase significantly as the population ages. It is becoming increasingly important to identify patients who will benefit from available and emerging therapies for the prevention and/or treatment of osteoporosis.

Formulary Digital Edition February 2010

Approaching the ideal selective estrogen receptor modulator for prevention and treatment of postmenopausal osteoporosis; Exenatide LAR: A sustained-release formulation of exenatide for the treatment of type 2 diabetes; and Agents in late-stage development for renal diseases

Drug Watch: Agents in late-stage development for renal disease (February 2010) (PDF)

Agents in late-stage development for renal disease

FDA Pipeline preview, February 2010 (Ceftobiprole, Carglumic acid, Miglustat, Nebivolol, Myocet, Pirfenidone, Davunetide, BiovaxID, EpiCept, CP-4126)

Recent FDA action (through February 2010) related to Ceftobiprole, Carglumic acid, Miglustat, Nebivolol, Myocet, Pirfenidone, Davunetide, BiovaxID, EpiCept, CP-4126

FDA Commissioner Hamburg builds agency's capabilities for bringing new therapies to patients

FDA actions in brief, February 2010 (Ampyra, Victoza, Actemra, Tropazone, Morphine sulfate oral solution, Fluzone High-Dose)

Recent FDA approvals (through February 2010) related to Ampyra, Victoza, Actemra, Tropazone, Morphine sulfate oral solution, Fluzone High-Dose

FDA finds no increased cardiovascular risk in patients using tiotropium

After completing a review of available tiotropium bromide inhalation powder (Spiriva HandiHaler, Pfizer) data, FDA released an updated communication, stating that in the regulatory body's opinion, available data does not support an association between the use of tiotropium, a commonly prescribed daily treatment for chronic obstructive pulmonary disease, and an increased risk of stroke, heart attack, or cardiovascular death.

Disease-modifying antirheumatic drugs prove most cost-effective in very early RA

Therapeutic strategies involving early conventional disease-modifying antirheumatic drugs or early biologics are preferred in treating very early rheumatoid arthritis, but the additional costs of early biologics may not be justified for all patients, according to a recent study reported in the Annals of Internal Medicine.

Vigabatrin (Sabril): An antiepileptic drug approved for the treatment of refractory complex partial seizures in adults and spasms in infants

New molecular entity: Vigabatrin (Sabril) was approved as an adjunctive treatment of refractory complex partial seizures in adults who have responded inadequately to several alternative treatments; and as monotherapy for pediatric patients with infantile spasms.

First-time generic approvals, February 2010

Generic drugs approved by FDA (through February 2010): Donepezil hydrochloride orally disintegrating tablets, Ibutilide fumarate injection, Risperidone orally disintegrating tablets in 0.5-mg, 2-mg, 3-mg, and 4-mg strengths

Higher dosage of losartan needed for maximal benefit in patients with CHF and left ventricular dysfunction

A dosage of losartan of 150 mg/day is superior to 50 mg/day for the treatment of patients with congestive heart failure (CHF).

Low-dose drug combination shows better outcomes for myeloma patients

Lenalidomide plus high-dose dexamethasone compared with lenalidomide plus low-dose dexamethasone did not result in superior time to progression, progression-free survival, or overall survival in patients with newly diagnosed myeloma, according to a recent trial.

ER niacin bests ezetimibe on measure of atherosclerosis

Extended-release niacin proved better than ezetimibe in favorably changing carotid intima-media thickness, a measure of atherosclerosis, in high-risk patients who were already receiving a statin.

Ecallantide (Kalbitor): A plasma kallikrein inhibitor approved for the treatment of acute attacks of hereditary angioedema

New molecular entity: Ecallantide (Kalbitor) was approved in December 2009, to treat hereditary angioedema (HAE).

Cardiovascular risk burden for women on the rise, while men see improvement

Middle-aged (35 to 54 years) women are gaining ground on their male counterparts in their prevalence of myocardial infarction (MI) and their cardiovascular risk factor scores, according to an examination of the National Health and Nutrition Examination Survey (NHANES) over time.

SSRIs lead to increased complications, including stroke, in depressed post-menopausal women

Selective serotonin uptake inhibitors present a small but notable increased risk of stroke and death in depressed post-menopausal women, according to a new study.

Combo of buproprion and nicotine lozenges may help smokers quit

Researchers have found that 1 in 5 smokers of at least 10 cigarettes a day will make a serious attempt to quit when offered help by health professionals and that the most effective cessation method employs a combination of bupropion SR and nicotine lozenges.

US dialysis patients face higher risk of drug errors

Close to 20% of kidney dialysis patients have an increased chance of significant bleeding because they receive the wrong blood-clot medication after undergoing a procedure to open a blocked artery, the Journal of the American Medical Assn. reports.

Children on Medicaid often misdiagnosed with mental illness

There's a direct relationship between children using Medicaid and current and present mental health problems, according to recent federal drug research.

Drug Watch: Anticoagulants and antiplatelet agents in late-stage development (January 2010)(PDF)

Anticoagulants and antiplatelet agents in late-stage development

Formulary Digital Edition January 2010

Erectile dysfunction and premature ejaculation: underlying causes and available treatments; Focus on roflumilast; Anticoagulants and antiplatelet agents in late-stage development

FDA's Safe Use Initiative to address preventable harm due to medication misuse, errors, and other related problems

Towards the end of 2009, FDA launched a new medication safety initiative.

Study: Prescription patterns and predictors of aldosterone antagonist use in heart failure

Heart failure (HF) guideline-recommended aldosterone antagonist therapy was received by less than one-third of eligible patients participating in a quality improvement registry who had been hospitalized for HF.