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
This review discusses current contraceptive options including recently approved, newer agents.
Intravenous dolasetron mesylate (Anzemet) should no longer be used to prevent nausea and vomiting associated with cancer chemotherapy in adult or pediatric patients due to an associated dose-dependant increase in QTc prolongation, according to a recent FDA drug safety communication.
Different opioids had different safety profiles when administered to older adults for noncancer pain, according to results from a new study published in the Archives of Internal Medicine.
New indication: Recombinant HPV quadrivalent (types 6, 11, 16, and 18) vaccine (Gardasil) was approved for the prevention of anal cancer and associated precancerous lesions due to HPV in persons aged 9 to 26 years.
This article reviews the emerging class of peripherally acting mu-opioid receptor antagonists and provides insight on formulary considerations when evaluating these agents.
Workers covered by ASOs surpassed the number of workers covered by fully insured arrangements in 2009
Base salaries for top health plan executives increased at the lowest rate in more than a decade
Government agencies will seek to hold not only companies, but also their officers and directors, accountable for lapses in compliance
Insurers must disclose new rates and justify increases that exceed certain thresholds
Adults in the United States are more likely than those in 10 other countries to forgo healthcare due to costs
Nursing home care can be delayed with community services
There are no signs that economic recession is slowing the growth of wellness programs with 74% of employers offering them
Many wonder whether a wave of consolidations will take place as smaller health plans seek economies of scale
As Republication leadership strives to dismantle the law, administration officials are taking steps to protect it
The obvious course of action for managed care organizations might be to take a wait-and-see attitude
Healthcare industry leaders have had to adopt a new way of thinking to prepare for business interruption
What is one thing everyone wants even though no one knows exactly what it is? An accountable care organization.
