FDA has approved an antipsychotic medication, haloperidol injection, USP (Sagent Pharmaceuticals), indicated for use in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette's disorder.
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The first step toward a national electronic system that will transform FDA?s ability to track the safety of drugs, biologics, and medical devices is up and running, according to a recent press release announcing the Mini-Sentinel Pilot project.
Hospital admission may lead patients to unintentionally discontinue medications for chronic diseases
Patients discharged from the hospital are at an elevated risk of not continuing their long-term medications for chronic diseases, and ICU admission appears to further increase this risk, according a recent study published August 24 in the Journal of the American Medical Association.
FDA has approved orphenadrine citrate injection, USP (Sagent Pharmaceuticals) a skeletal muscle relaxant as an adjunct to rest, physical therapy, and other measures to support relief from acute, painful musculoskeletal conditions.
FDA has issued a Safety Announcement warning that serious allergic reactions have been reported with the use of the antipsychotic medication asenapine maleate (Saphris).
Drugs such as Taxol, Cytarabine, Daunorubicin, Doxil, and Leucovorin are in short supply, delaying patients with various forms of cancer from getting the treatments they need or forcing them to seek alternative, possibly less-effective treatments, FDA announced recently.
FDA is alerting healthcare professionals that repackaged intravitreal injections of Roche Holdings' Avastin (bevacizumab) have caused a cluster of serious eye infections in the Miami, Fla., area.
FDA has approved onabotulinumtoxinA (Botox, Allergan) for injection for the treatment of urinary incontinence resulting from detrusor overactivity associated with a neurologic condition (eg, spinal cord injury [SCI], multiple sclerosis [MS]) in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
FDA has approved icatibant (Firazyr, Shire Human Genetic Therapies) injection for the treatment of acute attacks of hereditary angioedema (HAE) in patients 18 years of age and older.
FDA has notified healthcare professionals and patients that the antidepressant citalopram hydrobromide (Celexa, Forest Laboratories) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart.
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FDA has notified healthcare professionals and patients that the antidepressant citalopram hydrobromide (Celexa, Forest Laboratories) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart.
Linaclotide, an investigational drug for the relief of chronic constipation, appears to be effective and safe, according to the results of two phase 3 trials published in the August issue of the New England Journal of Medicine.
Colchicine, a widely used drug for the prevention and treatment of gout flares, interacts dangerously with many commonly prescribed pharmaceuticals, such as antibiotics, anti-hypertensive drugs, anti-fungals, immunosuppresants and protease inhibitors, according to a study published in the August issue of Arthritis & Rheumatism. However, most patients can take colchicines safely with these medications as long as the dose is adjusted, the study indicated.
FDA has approved tapentadol extended-release tablets (Nucynta ER, Janssen Pharmaceuticals), an oral analgesic taken twice daily, for the management of moderate-to-severe chronic pain in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
Management of chronic obstructive pulmonary disease: An emphasis on recently approved medications and products in the pipeline; Focus On Boceprevir: A new oral protease inhibitor for the treatment of chronic hepatitis C
FDA has approved crizotinib (Xalkori, Pfizer), the first and only therapy specifically for patients with locally advanced or metastatic non-small-cell lung cancer that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
The risk-benefit ratio is in favor of hormone replacement therapy (HRT) when initiated near menopause, according to new consensus statements issued by The North American Menopause Society, The American Menopause Society and the International Menopause Society and published in a recent paper in the July issue of Women?s Health.
The United States healthcare system is one of the least cost-effective in reducing mortality rates; while the United Kingdom is among the most cost-effective, according to a recent study published in the July issue of Journal of the Royal Society of Medicine Short Reports.
An antidote indicated for the treatment of acute cyanide poisoning judged to be life-threatening has launched.
Once-daily oral rivaroxaban (Xarelto, Bayer), a direct factor Xa inhibitor, appears to be as effective as dose-adjusted warfarin in preventing stroke or major embolism in patients with nonvalvular atrial fibrillation, according to a study published online August 10 in the New England Journal of Medicine.
Antibacterial drug use in children is associated with a dose-dependant increased risk of acquiring community-associated methicillin-resistant Staphylococcus aureus (Ca-MRSA), according to the results of a population-based, case-control study reported online August 1 in the Archives of Pediatrics & Adolescent Medicine.
FDA has approved brentuximab vedotin (Adcetris, Seattle Genetics) to treat 2 types of lymphoma.
FDA has approved vemurafenib (Zelboraf, Genentech), the second melanoma drug this year to improve overall survival. Zelboraf is indicated for the treatment of patients with late-stage (metastatic) or unresectable melanoma, the most dangerous type of skin cancer.
FDA has approved 2 new strengths (11.25 mg and 30 mg) for 3-month administration of leuprolide acetate for depot suspension (Lupron Depot-PED, Abbott) for the treatment of children with central precocious puberty.
FDA has approved emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Complera, Gilead Sciences), a complete single-tablet regimen for the treatment of HIV-1 infection in treatment-naïve adults.
How much do employers know regarding biologics and specialty pharmacy?
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