Formulary Watch |

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.

Diclofenac sodium topical solution (Pennsaid): Nonsteroidal anti-inflammatory topical solution approved for chronic management of knee osteoarthritis

New formulation: Diclofenac sodium topical solution (Pennsaid) was approved on November 5, 2009, to treat the signs and symptoms of osteoarthritis of the knee.

Exenatide drug label to include information on post-marketing surveillance of altered kidney function

In early November 2009, FDA approved revisions to the drug label for exenatide (Byetta, Amylin Pharmaceuticals), an injectable glucagon-like peptide-1 agonist for the treatment of type 2 diabetes mellitus.

Roflumilast: A new phosphodiesterase 4 inhibitor for chronic obstructive pulmonary disease

Roflumilast is a novel, orally active phosphodiesterase 4 inhibitor currently under review by FDA for the treatment of patients with moderate-to-severe COPD.

FDA Pipeline preview, January 2010 (Testosterone undecanoate injection, Telavancin, Ampligen, Doxepin, Everolimus, Aztreonam lysine, Erlotinib, TG4010, BSI-201, Midazolam, Aimspro, Motorgraft, BHR-100, Dextran sulfate)

Recent FDA action (through January 2010) related to testosterone undecanoate injection, telavancin, Ampligen, doxepin, everolimus, aztreonam lysine, erlotinib, TG4010, BSI-201, midazolam, Aimspro, Motorgraft, BHR-100, dextran sulfate

ACE inhibitors versus ARBs for ischemic heart disease: comparative effectiveness

A systematic review into the comparative effectiveness of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), or both, for patients with stable ischemic heart disease and preserved left ventricular (LV) function found that adding an ACE inhibitor to standard treatment can improve outcomes.

Pralatrexate injection (Folotyn): Folate analogue metabolic inhibitor approved for treatment of relapsed or refractory peripheral T-cell lymphoma

New molecular entity: Pralatrexate injection (Folotyn) was approved on September 24, 2009, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.

Erectile dysfunction and premature ejaculation: underlying causes and available treatments

This review examines the underlying causes associated with ED and PE and evaluates currently available treatment options and those under investigation.

Drug pricing, safety, access to dominate agenda in the year ahead

The new team heading up FDA will be firmly established and eager to implement new policies and programs. Payers, plans, and formulary committees will be watching key trends that will shape drug development and coverage in 2010:

First-time generic approvals, January 2010

Generic drugs approved by FDA (through January 2010): Nizatidine oral solution in the 15 mg/mL strength

Dabigatran compared to warfarin when given to patients with atrial fibrillation

Dabigatran, a new oral direct thrombin inhibitor, given to patients with atrial fibrillation at a dose of 110 mg was associated with rates of stroke and systemic embolism that were similar to those associated with warfarin, as well as lower rates of major hemorrhage.

FDA actions in brief, January 2010 (Cymbalta, Zyprexa, Zyprexa Relprevv, Intelence, Kalbitor, Istodax, Geodon, Vagifem, Seroquel XR, Clonidine ER Suspension, Clonidine ER Tablets, Wilate)

Recent FDA approvals (through January 2010) related to Cymbalta, Zyprexa, Zyprexa Relprevv, Intelence, Kalbitor, Istodax, Geodon, Vagifem, Seroquel XR, Clonidine ER Suspension, Clonidine ER Tablets, Wilate