New formulation: FDA approved pancrelipase delayed-release capsules (Pertyze, Digestive Care, Inc.) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.
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The Institute of Medicine reports that a number of issues are causing a number of barriers to successful HIV care in the United States.
Atrial fibrillation(AF) is the most common sustained cardiac arrhythmia and a potent risk factor for stroke. Here's a review of new oral anticoagulants for stroke prevention with AF.
The introduction of the immunomodulatory drugs and bortezomib, a proteasome inhibitor, has dramatically improved outcomes in patients with relapsed or refractory multiple myeloma.
Screening for hepatitis-C may soon become a routine screening for Baby Boomers.
A new study seems to indicate that adding cetuximab to the standard therapy for resected stage 3 colon cancer provides no additional benefits.
Recent FDA action (through July 2012) related to, morphine and oxycodone Dual Opioid platform, MoxDuo, QRxPharma, apixaban, Eliquis, Bristol-Myers Squibb, RG1068, Repligen, Multi-Stem, Athersys, Rivaroxaban, Xarelto, Janssen, Ocriplasmin intravitreal injection, ThromboGenics, Regorafenib, Bayer, Onyx Pharmaceuticals, Pregabalin, Lyrica, Lupin, Diclofenac sodium and misoprostol, Arthrotec, Watson, Next Choice One Dose, Plan B One-Step
The FDA recently announced a safety communication regarding the risk of seizures with MS who are starting dalfampridine.
A recent study from JAMA indicates that most Americans aren't meeting the necessary goals to lower CV risks.
Recent FDA Approvals (through July 2012) related to (Vivus, Gilead Sciences, Orasure, Pfizer, Ferring Pharmaceuticals, Eli Lilly, Bristol-Myers Squibb, Qiagen, Astellas Pharma US, Roche Molecular Systems, Arena Pharmaceuticals, Eisai)
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A review of drug therapies and research presented at the 2012 Scientific Session of the American Diabetes Association.
FDA has approved prednisone (Rayos, Horizon Pharma) delayed-release tablets (1 mg, 2 mg, and 5 mg) to treat a broad range of diseases including rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease.
In a unanimous vote (10-0), an FDA advisory committee recommended approval of the 0.3-mg dose of ranibizumab injection (Lucentis, Genentech, a member of the Roche Group) for treatment of diabetic macular edema.
FDA is ridding the market of single-ingredient oxycodone capsules and oral liquids that are being distributed without an FDA-approved application.
A recent study in Cancer Research suggests that modest caffeine consumption may be associated with a significantly lower relative risk of basal cell carcinoma.
The Centers for Disease Control and Prevention recently updated its 1991 recommendations for the management of hepatitis B virus (HBV)-infected healthcare providers and students to prevent HBV transmission to patients.
The Two Sister Study, funded in part by Susan Komen for the Cure, was conducted to examine the possible risks associated with fertility drugs and breast cancer. The results were published July 6 in the Journal of The National Cancer Institute.
To reduce the money spent on treatments that don't work, health plans and payers are examining closely how Comparative Effectiveness Research (CER) can steer patients and providers to more appropriate care. This approach is gaining momentum from the Patient Centered Outcomes Research Institute (PCORI), which is poised to distribute some $120 million in coming months—and nearly $400 million in 2013—to launch a range of CER projects.
FDA has approved aclidinium bromide inhalation powder (Tudorza Pressair, Forest) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
FDA has approved carfilzomib (Kyprolis, Onyx Pharmaceuticals) to treat patients with multiple myeloma who have received at least 2 prior therapies, including treatment with bortezomib (Velcade, Takeda) and an immunomodulatory therapy.
The results of a recent literature review suggest that only a high intake of vitamin D leads to a significant reduction in the risk of fracture.
FDA has approved once-daily phentermine and topiramate extended-release (Qsymia, Vivus) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index of 30 or greater, or 27 or greater in the presence of at least 1 weight-related comorbidity.
FDA recently approved the first over-the-counter test for HIV, providing a confidential in-home testing option for the virus that causes AIDS, with results in as little as 20 minutes.
FDA is alerting healthcare professionals to the possibility that a 32-mg single intravenous dose of ondansetron (Zofran, ondansetron hydrochloride, and generics) could lead to QT interval prolongation, putting patients at risk for a potentially fatal heart rhythm known as Torsades de Pointes.
FDA has approved once-daily oral emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead Sciences), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
FDA has approved Watson's generic diclofenac sodium and misoprostol delayed-release tablets (Arthrotec, G.D. Searle, a subsidiary of Pfizer), indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
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