An FDA panel has recommended that the agency approve Orexigen Therapeutics' and Takeda's obesity drug Contrave (naltrexone SR/bupropion SR). This makes the drug the first in a group of competitors to receive this recommendation, the Associated Press reported.
Nonanthracycline-containing chemotherapy regimens for the adjuvant treatment of operable stage I to III breast cancer are discussed, including efficacy and toxicity results from recent randomized clinical trials comparing anthracycline to nonanthracycline-containing regimens.
FDA voted today against approving 2 drugs for the prevention of prostate cancer: finasteride (Proscar, Merck) and dutasteride (Avodart, GlaxoSmithKline).
Focus on 2010: A year of novel pharmacologic agents in review; Azilsartan: A next-generation angiotensin II receptor blocker for the treatment of hypertension; Agents in late-stage development for the treatment of eye diseases
Agents in late-stage development for the treatment of eye diseases.
The commonly used pain reliever-acetaminophen-causes a significant increase in blood pressure in patients with pre-existing coronary artery disease, according to a randomized controlled trial published ahead of print in the October 18, 2010, Circulation.
Removal of marketed unapproved drugs (MUDs), such as that with oral colchicine, is part of FDA's Unapproved Drugs Initiative (launched in 2006).
Throughout 2010, Formulary's "Focus on" articles have examined 10 newly approved or investigational drugs of interest to pharmacy and therapeutics (P&T) committee members. Because many readers have said that they frequently refer to this column when making formulary decisions for hospitals, health systems, or managed care organizations, the editors have compiled this review of these agents, along with updates on the regulatory status of each.
Patients with systolic heart failure and mild symptomatology [New York Heart Association class II] taking the mineralocorticoid receptor antagonist-eplerenone-experienced a 37% reduction in death from cardiovascular causes or first hospitalization for heart failure, researchers demonstrated in a new study.
The new House leaders are gearing up for a vote to repeal health reform early next year. Such a move, though, is expected to be largely symbolic, as it's unlikely to pass the Senate or to override Obama's veto pen.
New molecular entity: Fingolimod (Gilenya) has recently been approved by FDA to treat patients with relapsing forms of MS to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
Generic drugs approved by FDA (through November 2010): Zafirlukast tablets and Desloratadine tablets
Specialty pharmaceuticals are expected to eventually replace non-specialty agents for the management of various conditions, including gout, lupus, diabetes, and hypercholesterolemia.
Azilsartan medoxomil (TAK-491), the prodrug form of azilsartan (TAK-536), is an ARB under review for FDA approval for the treatment of hypertension.
Rivaroxaban, an oral direct Factor Xa inhibitor given once daily was superior to warfarin in reducing the risk of stroke and non-central nervous system systemic embolism in patients with AF, with comparable rates of bleeding in the pre-specified on-treatment population, according to results from the ROCKET AF study.
About half of the top non-specialty drugs will become generic within the next 5 years, therefore the trend is for pharmaceutical companies to search and "co-develop" agents rather than investing large amounts of dollars in "R&D."
New molecular entity: Dabigatran etexilate (Pradaxa) was approved for stroke prevention in atrial fibrillation.
The outcomes associated with treating patients with chronic myelogenous leukemia improved dramatically when FDA approved imatinab. Subsequently, newer agents in the same therapeutic class have been approved, and early clinical studies suggest that they may become the new standard of care.
Recent FDA action (through, November 2010) related to Ezogabine, Solesta, Dutasteride, Finasteride, Octaplex, SF1126, MP4CO, Ensituximab, Naloxone, CBLB502.
Recent FDA Approvals (through November 2010) related to Xgeva, Kombiglyze XR, Egrifta, Baclofen injection, Vyvanse, Halaven, Nexterone, Axiron
FDA, in conjunction with Takeda Pharmaceuticals and researchers from the University of Pennsylvania and Kaiser Permanente Northern California, reported 5-year interim results of an ongoing, 10-year epidemiological study designed to evaluate whether pioglitazone (Actos) is associated with an increased risk of bladder cancer.
New molecular entity: Drospirenone/ethinyl estradiol/levomefolate calcium (Beyaz) was approved to treat symptoms of premenstrual dysphoric disorder and moderate acne in women at least 14 years of age, and to supplement folate levels in women wishing to use oral contraception.
Aspirin taken for several years and at doses ?75 mg a day was found to result in both a reduced 20-year risk of colorectal cancer incidence and mortality, according to an analysis published ahead-of-print on the Lancet website.
In consultation with FDA, McNeil Consumer Health, Division of McNeil-PPC Inc., has initiated a wholesale and retail level recall of Tylenol Cold Multi-Symptom liquid products; Children?s Benadryl Allergy Fastmelt Tablets, in cherry and grape flavors; Junior Strength Motrin Caplets, 24 count; and Rolaids Extra Strength Softchews, Cherry Flavor 36-count package.
Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene (Darvon and Darvocet) from the US market at the request of FDA. FDA also has informed generic manufacturers of Xanodyne?s decision, and they will be removing products containing propoxyphene from the market as well.
FDA has approved denosumab (Xgeva, Amgen), the first and only RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Xgeva was approved following a 6-month priority review by FDA. Xgeva is not indicated for the prevention of SREs in patients with multiple myeloma.
FDA has approved Lisdexamfetamine dimesylate (Vyvanse, Shire) capsules CII for the treatment of attention deficit hyperactivity disorder (ADHD) in adolescents aged 13 to 17 years.
FDA has approved onabotulinumtoxinA (Botox, Allergan Inc.) injection to prevent headaches in adult patients with chronic migraine.
With single-pill, fixed-dose combinations of antihypertensive agents, as well as triple-therapy, single-pill agents emerging, updated guidance on specific types of combination therapy for hypertension has emerged.
FDA has issued a complete response letter for lorcaserin?s (Arena and Eisai) New Drug Application. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in some patients who are obese?or patients who are overweight?and have at least 1 weight-related co-morbid condition.
