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FDA Actions in Brief August 2012
Recent FDA Approvals (through August 2012) related to (CSL Limited, GlaxoSmithKline Biologicals, ID Biomedical Corp, MedImmune Vaccines, Novartis Vaccines and Diagnostics Limited, Sanofi Pasteur, Genentech, Talon Therapeutics, Amarin, Regeneron Pharmaceuticals, Horizon Pharma, Forest Pharmaceuticals, Onyx Pharmaceuticals, Novartis, Pfizer, Sagent Pharmaceuticals)
The 2012-2013 influenza (flu) vaccine formulation (Afluria, CSL Limited; Fluarix, GlaxoSmithKline Biologicals; FluLaval, ID Biomedical Corp.; FluMist, MedImmune Vaccines; Fluvirin, Novartis Vaccines and Diagnostics Limited; and Fluzone, Fluzone High-Dose, and Fluzone Intradermal, Sanofi Pasteur) was approved for the 2012-2013 influenza season.
Ranibizumab injection (Lucentis, Genentech) was approved for treatment of diabetic macular edema, a sight-threatening eye disease that occurs in people with diabetes.
Vincristine sulfate liposome injection (Marqibo, Talon Therapeutics) was approved for the treatment of adult patients with Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following 2 or more anti-leukemia therapies.
Ziv-aflibercept (Zaltrap, Sanofi and Regeneron Pharmaceuticals) injection was approved for intravenous infusion, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.
Prednisone (Rayos, Horizon Pharma) delayed-release tablets (1 mg, 2 mg, and 5 mg) were approved to treat a broad range of diseases including rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease.
Aclidinium bromide inhalation powder (Tudorza Pressair, Forest Pharmaceuticals) was approved for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Carfilzomib (Kyprolis, Onyx Pharmaceuticals) was approved to treat patients with multiple myeloma who have received at least 2 prior therapies, including treatment with bortezomib (Velcade, Takeda) and an immunomodulatory therapy.
Everolimus (Afinitor, Novartis) was approved for use in combination with exemestane (Aromasin, Pfizer) to treat certain postmenopausal women with advanced hormone-receptor positive HER2-negative breast cancer.
Oxacillin for injection, USP (Sagent Pharmaceuticals), in 3 latex-free, preservative-free vial presentations, was approved for the treatment of infections caused by penicillinase producing staphylococci, which have demonstrated susceptibility to the drug.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
