In less than 1 full year at the helm of FDA, Margaret (Peggy) Hamburg has worked to reposition FDA as a public health agency able to ensure the safety and quality of the nation's food supply and medical products.
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Recent FDA approvals (through February 2010) related to Ampyra, Victoza, Actemra, Tropazone, Morphine sulfate oral solution, Fluzone High-Dose
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.
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.
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.
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
A dosage of losartan of 150 mg/day is superior to 50 mg/day for the treatment of patients with congestive heart failure (CHF).
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.
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.
New molecular entity: Ecallantide (Kalbitor) was approved in December 2009, to treat hereditary angioedema (HAE).
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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.
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.
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.
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.
There's a direct relationship between children using Medicaid and current and present mental health problems, according to recent federal drug research.
Anticoagulants and antiplatelet agents in late-stage development
Erectile dysfunction and premature ejaculation: underlying causes and available treatments; Focus on roflumilast; Anticoagulants and antiplatelet agents in late-stage development
Towards the end of 2009, FDA launched a new medication safety initiative.
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.
New formulation: Diclofenac sodium topical solution (Pennsaid) was approved on November 5, 2009, to treat the signs and symptoms of osteoarthritis of the knee.
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 is a novel, orally active phosphodiesterase 4 inhibitor currently under review by FDA for the treatment of patients with moderate-to-severe COPD.
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
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.
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.
This review examines the underlying causes associated with ED and PE and evaluates currently available treatment options and those under investigation.
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