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.
Contraceptive treatments: A review of current hormone options and newer agents for women; Focus on dabigatran; Agents in late-stage development for the treatment of cystic fibrosis.
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.
FDA has approved vilazodone HCl tablets (Viibryd, Clinical Data) for the treatment of adults with major depressive disorder.
FDA approved spinosad (Natroba, ParaPRO LLC) Topical Suspension 0.9% for the treatment of head lice infestation in patients aged 4 years and older.
With the healthcare reform law repeal exercise behind them, Congressional leaders can get down to focusing on ways to eliminate or repair some of the more contentious reform provisions and to modify others, according to policy watchers.
FDA has sent MannKind Corp. a complete response letter regarding the company?s NDA for Afrezza Inhalation Powder for the treatment of adult patients with type 1 and type 2 diabetes for the control of hyperglycemia.
Concern that its potential clot-preventing drug vorapaxar increased the risk of bleeding in stroke victims has prompted Merck & Co. to halt a late-stage study of the drug, the Associated Press reported.
Elderly patients have difficulty with long-term adherence to medications following myocardial infarction, and this is significantly worse among those with kidney dysfunction, according to a study published online January 13 in the Clinical Journal of the American Society of Nephrology, HealthDay News reported.
Antiepileptic drugs may increase the risk of nontraumatic fractures in patients aged 50 years and older, according to a study published in the January issue of the Archives of Neurology, HealthDay News reported.
