Generic drugs approved by FDA (through December 2010): Levocetirizine tablets
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New combination: Saxagliptin and metformin extended release (Kombiglyze XR) was approved to improve glycemic control in adults with type 2 diabetes mellitus.
Antihypertensive therapy with an angiotensin receptor blocker is not associated with reductions in cardiovascular or all-cause mortality compared to non-ARB-based regimens in patients with type 2 diabetes, according to researchers at the Massachusetts College of Pharmacy and Health Sciences.
Recent FDA Approvals (through December 2010) related to Amturnide, Prezista, Safyral, Gardasil, Atelvia
As compared to fluorouracil, doxorubicin, and cyclophosphamide, an adjuvant taxane-based regimen containing docetaxel, doxorubicin, and cyclophosphamide was shown to increase the rate of disease-free survival by 32% among women with high-risk, node-negative breast cancer.
FDA is requiring a new warning be added to the prescribing information for saquinavir (Invirase) detailing the drug's potential to prolong both QT and PR intervals on an electrocardiogram, and thus potentially cause the dangerous abnormal heart rhythms called torsades de pointes and complete heart block.
Technosphere insulin is an inhaled form of regular human insulin with a rapid onset of action (~15 min) that is being considered for approval for the treatment of type 1 and type 2 diabetes mellitus. Technosphere insulin has shown efficacy in decreasing the level of glycosylated hemoglobin in a dose-dependent manner.
Top-selling pediatric OTC analgesic, cough and cold, allergy, and gastrointestinal liquid medications in the United States are plagued with highly variable and inconsistent dosing directions and measuring devices, according to a study published ahead-of-print on the Journal of the American Medical Association's website.
Researchers from the Cincinnati Children's Hospital Medical Center have demonstrated that the tumor necrosis factor-alpha inhibitor etanercept is associated with significant increases in height, weight, and body mass index in children with juvenile idiopathic arthritis, according to a study recently published in Arthritis & Rheumatism.
Oncology treatment and benefits are changing. Buy-and-bill, the traditional methodology that had physicians buy chemotherapeutic products, treat in the office, and bill the payer, is going the way of surgery by barbers. But no one is quite sure what will replace the one-time standard of payment.
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Pfizer voluntarily withdraws sitaxsentan from the market worldwide and halts ongoing clinical trials
Based on "a review of emerging safety information from clinical trials and postmarketing reports," Pfizer announced it would be voluntarily withdrawing sitaxsentan (Thelin), the manufacturer's pulmonary artery hypertension (PAH) treatment from the market worldwide.
The political tensions wrought by last November's mid-term elections will play out in a number of situations affecting health plans and pharmaceutical companies this year.
Patients who switch statins have lower persistence to therapy compared to those who don't switch, found Gary J. Tereso, PharmD, director of pharmacy services at Health New England, Springfield, Mass.
A newly approved drug, denosumab (Xgeva, Amgen), delays skeletal-related side effects for 5 months longer compared to zoledronic acid (Zometa and Reclast, Novartis) in patients with breast cancer and bone metastases, according to phase 3 trial results presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium, San Antonio, Texas.
Plaque psoriasis: A review of recent guidelines and pharmacologic therapies; Technosphere insulin: An inhaled mealtime insulin for the treatment of type 1 and type 2 diabetes mellitus; Agents in late-stage development for the treatment of osteoporosis and related bone disease
Treatment of recurrent herpes simplex labialis with combination 5% acyclovir and 1% hydrocortisone cream is safe in adolescents. In a study of a 5-day treatment course, no safety concerns were identified, said Anders Strand, MD, PhD, at the 45th midyear meeting of the American Society of Health Systems Pharmacists, in Anaheim, Calif.
Few patients who are prescribed varenicline to assist in smoking cessation remain on the therapy, according to retrospective data presented during the 45th midyear meeting of the American Society of Health Systems Pharmacists, in Anaheim, Calif.
FNIH has released 'Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership' in the Annals of Internal Medicine.
Among patients with CAD, participating in a secondary prevention program featuring a clinical pharmacy specialist and registered nurse is associated with lower healthcare expenditures, according to research published in the November issue of Pharmacotherapy, HealthDay News reported.
FDA has issued warnings regarding 2 products, Man Up Now and Vigor-25, both marketed as natural dietary supplements to enhance male sexual performance.
Further reductions in LDL cholesterol with more intensive statin regimens safely produce definite further reductions in vascular events, even down to very low LDL levels, lower than current targets, according to the results of 2 meta-analyses, as reported Nov. 8 online by The Lancet.
FDA is recommending removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.
A medication for skeletal-related events in patients with bone metastases was shown to significantly improve bone metastasis-free survival rates in prostate cancer patients, according to a new trial.
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.
In consultation with FDA, McNeil Consumer Health, Division of McNeil-PPC Inc., has initiated a wholesale and retail level recalls.
CNS Therapeutics announced that FDA has approved baclofen injection (Gablofen) for use in the management of severe spasticity. The drug gives providers an easy-to-administer, cost-effective intrathecal baclofen treatment option, according to the company.
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