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All News - Page 93
FDA opens up generic competition
March 12, 2015
FDA released new draft guidance designed to make it easier for generic manufacturers to introduce competition to 38 existing drug products, according to the agency’s Federal Register notice.
FDA updates Chantix label to include possible alcohol interaction
March 11, 2015
FDA has warned that the smoking cessation drug varenicline (Chantix) can interact with alcohol, resulting in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia.
Biosimilar drugs could save US billions
March 11, 2015
FDA's approval of the “generic" biologic prescription version of cancer medicine Neupogen opens the door to a movement that could save the US healthcare system tens of billions of dollars a year, according to Forbes.
Sepsis patients return to hospital for preventable reasons; better post care needed
March 11, 2015
Better post-hospital care is needed for sepsis patients to avoid readmissions that drive up costs and interfere with recovery, according to a study published in the March 10 issue of JAMA.
Anticholinergic drugs linked to higher risk for pneumonia in elderly
March 10, 2015
Taking commonly used medications with anticholinergic effects is associated with a significantly higher risk for developing pneumonia, according to a study published recently in the Journal of the American Geriatrics Society.
First therapy for pediatric high-risk neuroblastoma approved by FDA
March 10, 2015
FDA approved dinutuximab (Unituxin, United Therapeutics) as part of first-line therapy for pediatric patients with high-risk neuroblastoma, a type of cancer that most often occurs in young children.
FDA drug approvals-March 2015
March 6, 2015
FDA actions in brief, breakthrough designation, recommended for approval, priority review, fast-track designations
FDA approves first biosimiar Zarxio
March 6, 2015
FDA approved filgrastim-sndz (Zarxio, Sandoz), the first biosimilar product approved in the United States.
Paracetamol: Is it as safe as we thought?
March 6, 2015
Paracetamol (acetaminophen) is still safer than nonsteroidal anti-inflammatory drugs (NSAIDs), but there is concern about its potential for some side effects not usually considered related to paracetamol, according to a study published in the Annals of Rheumatic Diseases.
New antifungal drug approved by FDA
March 6, 2015
Cresemba (isavuconazonium sulfate, Astellas Pharma US) has just been approved by FDA for the treatment of adults suffering from the rare but serious infections of invasive aspergillosis and invasive mucormycosis. Individuals with weakened immune systems are most prone to these infections.
Corticosteroids recommended for severe pneumonia
March 5, 2015
Because the use of corticosteroids in patients with severe community-acquired pneumonia is controversial, researchers in Spain set out to determine the benefits versus the pitfalls of using the adjunctive therapy.
Fondaparinux beats heparin in major study
March 5, 2015
The anticoagulant medication Fondaparinux (Arixtra) was associated with reduced major bleeding events and improved survival, compared to low-molecular-weight heparin (LMWH) in a large randomized clinical trial involving patients with non–ST-segment elevation myocardial infarction (NSTEMI), according to a new study.
FDA issues new labeling indications for testosterone replacement therapy
March 4, 2015
FDA has issued new labeling indications for prescription testosterone replacement therapy (TRT) in order to clarify that it is not indicated for men who have a normal age-related decline in testosterone. The new labeling also will provide warnings on the risk of cardiovascular injuries that may occur with the use of TRT.
FDA approves additional indication for Opdivo
March 4, 2015
FDA has expanded the approved use of nivolumab (Opdivo, Bristol Myers Squibb) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Drug shortages mobile app launched by FDA
March 4, 2015
FDA has launched its first mobile application (app) designed to provide quick access to important information on medications that are in short supply. Current or resolved drug shortages, as well as product discontinuations, can be identified by using the new app.
New device prevents cancer tumors from coming back
March 3, 2015
A new nanodevice developed by MIT researchers can help prevent cancer tumors from growing back after chemotherapy, according to a new study published in the Proceedings of the National Academy of Sciences for the week of March 2.
Hospital pharmacists protest higher cancer drug costs in survey
March 3, 2015
A national survey of pharmacy professionals released March 3 found that a move to specialty drug distribution of three primary cancer drugs is resulting in higher costs to hospitals and reduced availability of the medications.
Class action suit targets asthma drug
March 3, 2015
Xolair (omalizumab), a drug used to treat allergic asthma in adults and children 12 years and older, has been linked to significant health issues such as mini-strokes, heart attacks and blood clots, according to the law firm of Baron and Budd, which has offices in Dallas, Texas, and several other cities.
Post-MI NSAID/anticoag combo may increase risk of CV bleeding events
March 2, 2015
Among patients receiving antithrombotic therapy (to prevent the formation of blood clots) after a heart attack, the use of nonsteroidal anti-inflammatory drugs (NSAIDs) was associated with an increased risk of bleeding and events such as heart attack, stroke or cardiovascular death, even after short-term treatment, according to a study in the February 24 issue of JAMA.
New guidance on generic opioids, biosimilars labeling coming from FDA
March 2, 2015
FDA’s Center for Drug Evaluation and Research (CDER) will release a document designed to provide manufacturers with guidance on the evaluation of abuse-deterrent properties of generic opioids by the end of 2015. It will also release a document on biosimilars product labeling in the same time period.
Fast antibiotics reduce PICU needs, mortality of pediatric cancer patients
February 27, 2015
Pediatric cancer patients who receive antibiotics within 60 minutes of reporting fever and showing neutropenia (low neutrophil count), go on to have decreased intensive care needs and lower mortality compared with patients who receive antibiotics outside the 60-minute window, according to a University of Colorado Cancer Center study published in Pediatric Blood & Cancer.
New, more potent diabetes drug approved by FDA
February 27, 2015
FDA has approved a new once-daily, long-acting basal insulin, Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL, Sanofi) for the treatment of adults with type 1 and type 2 diabetes mellitus. It is described as a more potent follow-up to the manufacturer’s insulin product Lantus (insulin glargine [rDNA origin] injection, 100 U/mL).
FDA approves new antibacterial drug Avycaz
February 27, 2015
FDA has approved ceftazidime-avibactam (Avycaz, Actavis and Forest), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options.
Group calls on FDA to remove antifungal from market
February 27, 2015
The oral formulations of the antifungal medication ketoconazole should be removed from the market immediately, Public Citizen said this week in a petition to the Food and Drug Administration (FDA).
Most medications found better than Tylenol for knee pain
February 26, 2015
Most treatments for pain caused by knee osteoarthritis helped alleviate pain better than acetaminophen (Tylenol) – with one exception, according to a study published in the January 6 issue of the Annals of Internal Medicine
Prostate cancer drug could help Alzheimer's patients
February 26, 2015
The prostate cancer medication leuprolide acetate (Lupron Depot), used in conjunction with acetylcholinesterase inhibitor (AChEI), slowed memory loss in female Alzheimer’s patients, according to a new study.
Resistance to malaria drug increasing
February 25, 2015
Resistance to the malaria medication artemisinin extends across much of Myanmar in Southeast Asia, according a new study, published online February 19 in The Lancet Infectious Diseases.
Higher opioid doses linked to increase in depression: Study
February 24, 2015
Patients who increased doses of opioid medicines to manage chronic pain were more likely to experience an increase in depression, according to a study published in the February issue of Pain.
FDA clears closure system to permanently treat varicose veins
February 23, 2015
The VenaSeal system is newly approved to permanently treat varicose veins by sealing the affected veins using an adhesive agent, known as n-butyl-2-cyanoacrylate, which polymerizes into solid material after being injected into the vein.
Actavis gains final FDA approval for generic Subutex
February 23, 2015
Actavis has received final approval from FDA on its Abbreviated New Drug Application for a generic version of Reckitt Benckiser's Subutex (buprenorphine 2 mg and 8 mg sublingual tablets) indicated for treatment of opioid dependence.
