FDA and the Federal Trade Commission (FTC) issued a warning letter to Flu and Cold Defense LLC (Boca Raton, Fla.) for making misleading, unproven claims about its GermBullet inhaler, and said the company has been marketing an untested inhaled formula as a flu remedy in violation of drug safety regulations.
FDA has approved mipomersen sodium (Kynamro, Genzyme and Isis Pharmaceuticals) once-a-week injection as an addition to lipid-lowering medications and diet to treat patients with a rare type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). The addition of Kynamro helps to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and non-high density lipoprotein-cholesterol (non HDL-C).
The public is generally satisfied with cancer research progress over the past 20 years. However, they believe it takes too long for new cancer drugs to reach patients and that their countries invest too little in fighting cancer, according a global survey.
Recent FDA action (through January 2013) related to, IPX066, Afatinib, Enobosam, GTx-024, Elafin, Ezatiostat HCL, Tranexamic acid tablets, Lamotrigine extended-release tablets
New molecular entity: A benzodiazepine indicated for adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients age 2 years or older.
Recent FDA Approvals (through January 2013) related to (Deferasirox, Exjade, Novartis, bevacizumab, Avastin, Roche Group, trivalent influenza vaccine, Flublok, Protein Sciences, Budesonide, Uceris, Santarus, pooled plasma blood product, Octaplas, Octapharma, Sumatriptan iontophoretic transdermal system, Zecuity, NuPathe, onabotulinumtoxinA, Botox, Allergan
A look at the evidence in support of supplemental vitamin use during pregnancy.
Diabetes mellitus is a chronic condition characterized by elevated blood glucose that occurs as a result of impaired insulin action or production. This article focuses on current recommendations for the treatment of type 2 diabetes and methods of controlling co-occurring conditions.
The specialty pharmaceutical market is currently fragmented with extreme variation in knowledge/education, patient care management, service, and outcomes.
Optum and Mayo Clinic have partnered to launch Optum Labs, an open facility designed to enable collaborative research and innovation focused on better patient care.
Treatment of advance kidney cancer has evolved considerably over the last decade, and multiple agents are available.
A stool substitute therapy has promise as an approach to eradication of refractive Clostridium difficile (C difficile) in a proof-of-principle study published January 9 in the inaugural issue of Microbiome.
Medical used of probiotics could be significant in minimizing Clostridium difficile (C difficile) infection among hospitalized patients taking antibiotics.
Making prescription refills more affordable and easier to get may reduce disparities among hypertension patients, according to a study.
The cost of managing diabetes patients is extremely high, and many patients still experience poor glycemic control and renal complications, according to results of a study.
FDA issued a draft guidance last month to help the industry in the development of opioid drug formulations with abuse-deterrent properties, saying it considers development of these products a high public health priority.
The use of clarithromycin in the first trimester of pregnancy may increase the risk of miscarriage, according to researchers in Denmark. However, the researchers did not find a link between exposure to clarithromycin and major congenital malformations.
Influenza activity remains elevated in most of the country, according to the latest FluView report from the CDC for the week of January 13-19.
The cost of managing diabetes patients is extremely high, and many patients still experience poor glycemic control and renal complications, according to results of a study published online in the journal Diabetes Care.
Patients with erectile dysfunction (ED) have a 44% increased risk of cardiovascular (CV) events, according to a study, published online in Circulation: Cardiovascular Quality and Outcomes.
Social ties to industry appear to influence physician prescribing behaviors, according to a recent study published online January 7 in JAMA Internal Medicine (formerly Archives of Internal Medicine).
An FDA advisory committee voted 19 to 10 in favor of moving hydrocodone combination drugs such as Vicodin, Lortab, and Norco into the more restrictive Schedule II category of controlled substances, MedPage Today reported.
Healthcare professionals have been notified by Otsuka and FDA of significant liver injury associated with the use of tolvaptan (Samsca, Otsuka).
FDA has expanded the approved use of deferasirox (Exjade, Novartis) to treat patients aged 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).
The spike in flu cases over the past month, along with limited supplies of influenza vaccine and Tamiflu across the United States, has led FDA Commissioner Margaret Hamburg to issue guidance to pharmacists and other healthcare providers.
The Centers for Disease Control’s (CDC) early estimates of the effectiveness of the seasonal influenza vaccine is 62%.
FDA expanded the approved use onabotulinumtoxinA (Botox, Allergan) to treat adults with overactive bladder (OAB) who cannot use or do not adequately respond to a class of medications known as anticholinergics
Researchers examining the effectiveness of cefixime in the treatment of gonorrhea found a relatively high treatment failure rate, raising concern that gonorrhea may become untreatable, according to results published January 9 in the Journal of the American Medical Association.
FDA has approved sumatriptan iontophoretic transdermal system (Zecuity, NuPathe) for the acute treatment of migraine with or without aura in adults. Zecuity is a single-use, battery-powered patch that actively delivers sumatriptan, the most widely prescribed migraine medication, through the skin.
FDA’s recent approval of crofelemer (Fulyzaq, Salix Pharmaceuticals, under license from Napo Pharmaceuticals), 125 mg delayed-release tablets, the first anti-diarrheal drug for HIV/AIDS patients taking antiretroviral therapy (ART), is a significant step forward in addressing the unmet medical need of people with HIV/AIDS on ART who experience noninfectious diarrhea, which often can lead to reduced treatment compliance.