Recent FDA action (through June 2011) related to oxycodone, aflibercept opthalmic solution, icatibant, eculizumab, asimadoline, anthrax vaccine, SBC-102 enzyme replacement therapy, ciprofloxacin, mitosol, MORAb-004 and MORAb-066, levofloxacin.
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In a recently published observational registry study, researchers have demonstrated that the utilizatio of evidence-based therapies in patients experiencing ST-elevation myocardial infarction is on the rise.
Low-cost generic drug programs pioneered by Wal-Mart and other big-box retailers are a mixed blessing for patients with diabetes.
Pfizer?s second attempt at an abuse-resistant formulation of oxycodone (Remoxy) recently received a complete response letter (CRL) from FDA. Just a week earlier, FDA approved another of the drug maker?s abuse-resistant products ? immediate-release Oxecta (oxycodone HCl) ? for the management of acute and chronic moderate-to-severe pain.
FDA has announced more conservative dosing recommendations for erythropoiesis-stimulating agents (ESAs) when they are used to treat anemia in patients with chronic kidney disease (CKD) because of increased risk of cardiovascular events such as stroke, thrombosis, and death.
Crizotinib demonstrated an association with a sharp increase in survival rates for patients with advanced non-small cell lung cancer with an anaplastic lymphoma kinase positive genetic alteration, according to the results of a study presented at the annual meeting of the American Society of Clinical Oncology.
Safety information regarding varenicline will be added to the Warnings and Precautions section of the label and to the patient Medication Guide because smoking cessation aid varenicline may be associated with an increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease.
FDA announced reports of medication errors involving risperidone and ropinirole in which some patients who took the wrong medication needed to be hospitalized.
Study shows that several common antiepileptic drugs pose the risk of major congenital malformations and that risk increases dose-dependently.
FDA announced changes to safety labels for simvastatin, Vytorin, and Simcor, including dosing recommendations and is advising physicians to limit the use of 80-mg simvastatin due to an increased risk of myopathy.
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The Center for Drug Evaluation and Research recently announced that it will elevate the Office of Compliance to a Super Office to continue to ensure the safety, quality, and integrity of drugs in America, according to a memo from CDER Director Janet Woodcock.
Budesonide/Formoterol maintenance and reliever therapy is an effective option for patients requiring treatment adjustments across Steps 2 to 4 of the Global Initiative for Asthma guidelines, according to the results of a study published online, June 2 in Respiratory Research.
Angiotensin receptor blockers do not increase the risk of developing cancer in patients using the medications, FDA announced recently after a safety review.
Aidapak Services has issued a voluntary recall of a large number of repackaged drug products after learning of the potential cross contamination of non-penicillin with penicillin drug products repackaged in the same facility.
FDA is assessing new information indicating an association between birth control pills containing the progestin hormone drospirenone and an increased risk of deep vein thrombosis and pulmonary embolus.
An investigational, fully human monoclonal antibody called ACZ885 (canakinumab) provided better pain relief in treating severe gouty arthritis, and it reduced the risk of new attacks by up to 68% compared with an injectable steroid (triamcinolone acetonide), according to results of 2 phase 3 trials announced by Novartis, the drug?s manufacturer.
A 56-week phase 3 data for orphan drug lomitapide are consistent with 26-week data, showing that the drug significantly reduced low density lipoprotein cholesterol levels in patients with homozygous familial hypercholesterolemia, according to the drug?s manufacturer Aegerion Pharmaceuticals.
Lacosamide (Vimpat, UCB) appears both cost- and utility-effective as an add-on therapy for adults with uncontrolled partial-onset seizure, according to a pharmacoeconomics analysis that was recently presented at the International Society for Pharmacoeconomics Research.
Dietary calcium intake above 750 mg does not provide added benefit against risk of fractures or osteoporosis, according to the results of a large prospective longitudinal cohort study reported in the May 24 issue of the British Medical Journal.
Use of short- and long-acting inhaled anticholinergic medications in men with chronic obstructive pulmonary disease is associated with an increased risk of acute urinary retention, according to the results of a study published in the May 23 issue of Archives of Internal Medicine.
FDA announced May 18 to the public new restrictions to the prescribing, dispensing, and use of rosiglitazone-containing medications (Avandia, Avandamet, and Avandaryl, GlaxoSmithKline [GSK]) as part of a Risk Evaluation and Mitigation Strategy.
An FDA advisory panel recommended fenofibric acid (Trilipix, Abbott) still be marketed for use but voted unanimously that Abbott be required to conduct a new study to determine whether a Trilipix-statin combination reduces heart attacks.
Nearly 20% of young adults in the United States may have high blood pressure, according to an analysis of the NIH-funded National Longitudinal Study of Adolescent Health (Add Health) published online May 23 in Epidemiology.
FDA has approved a sterile, injectable gel (Solesta, Oceana Therapetucis) as a treatment for fecal (bowel) incontinence in adult patients who have not responded to conservative therapy such as dietary control.
An investigational fixed-dose therapy showed promising results in lowering blood pressure compared with study comparators, according to the results of three phase 3 studies presented at the 26th annual American Society of Hypertension (ASH) Scientific Meeting and Exposition in New York.
Patients with metastatic castration-resistant prostate cancer treated with the investigational agent abiraterone acetate plus low-dose prednisone/prednisolone showed a significant improvement in overall survival compared to patients treated with prednisone/prednisolone plus placebo, according to a phase 3 study published in the May 26 issue of the New England Journal of Medicine.
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