Unprecedented levels of drug shortages, especially those drugs for which there are no substitutes, has prompted legislators to take action. Since the inception of the FDA Drug Shortage Program in 2000, the agency has been tracking the nation?s prescription pharmaceuticals and publishing a list of drugs in short supply.
FDA is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor because of the risk for serious maternal heart problems and death.
Merck Serono Europe informed the European Medicines Agency that it was withdrawing its marketing authorization application for oral cladribine (Movectro), 10-mg tablets, intended for the treatment of relapsing-remitting multiple sclerosis.
Forest Laboratories $1.2 billion acquisition of Clinical Data, the developer of Viibryd (vilazodone HCl) for the treatment of adults with major depressive disorder, is expected to allow Forest to leverage its existing presence in the antidepressant category.
FDA has approved Corifact (CSL Behring), the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.
FDA has granted fast-track designation to a novel endothelial cell-based therapy (Vascugel, Pervasis) for the prevention of hemodialysis access failure in patients with end-stage renal disease.
The $20.1 billion acquisition of Genzyme by Sanofi-aventis will allow Sanotif-aventis to expand its footprint in biotechnology and give it an edge in the market for drugs for rare diseases, according to experts.
Zinc, in lozenge or syrup form, is beneficial in reducing the duration and severity of the common cold in healthy people, when taken within at least 24 hours of onset of symptoms, according to a new report published in the Cochran Library.
The name change is meant to unify AmeriChoice with other Medicaid health plans under the UnitedHealthcare banner.
Findings by the Employee Benefit Research Institute (EBRI) show that both employers and workers say they are not very knowledgeable about health reform, but that employers say they are likely to pass along any health benefit cost increases to workers?and, mostly, workers are expecting such cost increases.
The new standards call on medical practices to be more patient-centered, and reinforce federal ?meaningful use? incentives for primary care practices to adopt health information technology.
A Booz & Company study titled "The Future of Heath Insurance" forecasts how health reform will shift the landscape for health plans, predicting they will emerge with specialized capabilities targeted to specific customer segments.
FDA has approved hydroxyprogesterone caproate injection (Makena [formerly known as Gestiva], Hologic and KV Pharmaceutical Co.), the first drug to help prevent premature delivery before 37 weeks in women who have had at least 1 previous preterm birth.
FDA has approved a vaccine for preventing meningococcal disease in children.
Escitalopram, a selective serotonin reuptake inhibitor, at doses of 10 or 20 mg/d significantly reduced hot flash frequency and severity compared with placebo, according to a recent multi-center, double-blind study.
FDA has approved gabapentin (Gralise, Depomed and Abbott Products) tablets for once-daily treatment of post-herpetic neuralgia.
Medication errors involving analgesics, including mistakes in prescribing, are a major contributor to suboptimal therapeutic outcomes and preventable adverse patient events, according to a study published in the Journal of Pain, reported Newswise.com.
FDA has issued a complete response letter to Eisai for its rabeprazole sodium extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI) under review for the healing and long-term maintenance of healing and symptom resolution of erosive GERD, and for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.
FDA has issued a complete response letter for Orexigen?s and Takeda?s Contrave (naltrexone HCl/bupropion HCl) extended-release tablets for the treatment of obesity, including weight loss and maintenance of weight loss.
An increase in febrile seizures in children following vaccination with Fluzone warrants further investigation, according to a report from FDA.
Agents in late-stage development of cystic fibrosis
Recent FDA action (through, January 2011) related to Afrezza, Nuvigil, Opana ER, Liprotamase, Erwinaze, Telaprevir, SNS01-T, XL184, QLT091001, Fidaxomicin.
Dabigatran etexilate (Pradaxa) was approved by FDA for the prevention of stroke and thrombosis in patients with atrial fibrillation.
FDA released a safety communication to inform prescribers and patients about a possible increased risk of death in persons with certain kinds of short stature treated with recombinant human growth hormone (also known as somatropin).
New molecular entity: Risedronate sodium delayed-release tablets (Atelvia) were approved for the treatment of postmenopausal osteoporosis
The recently FDA-approved oral direct thrombin inhibitor, dabigatran, may be cost-effective compared to the standard-of-care therapy of adjusted-dose warfarin in patients requiring anticoagulation for stroke prevention in atrial fibrillation, according to a pharmacoeconomic evaluation published in the Annals of Internal Medicine.
With Republicans taking over the House last month and increasing their clout in the Senate, Congressional leaders are contemplating broad federal budget cuts and much more aggressive oversight of administration health policy and regulatory programs.
Recent FDA Approvals (through January 2011) related to Fortesta, Natroba, Abstral, Acetadote, Viibryd, Intelence
Individuals involved in formulary decision-making processes at US health plans were surveyed to determine their current and future use of health economic and outcomes research.
Generic drugs approved by FDA (through January 2011): Fentanyl buccal tablets
