The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have received accelerated approval by the FDA for use together for a fifth indication: treatment of unresectable or metastatic solid tumors with a BRAF V600E mutation in patients ≥6 years old who have progressed following prior treatment and have no satisfactory alternative treatment options. The combination is not approved for treatment of colorectal cancer because of known intrinsic resistance to BRAF inhibition and dabrafenib is not approved for use in patients with wild-type BRAF...

Fluticasone furoate nasal spray (Veramyst - GSK) is now available for once-daily treatment of seasonal and perennial allergic rhinitis in adults and children ≥2 years old. It is similar to fluticasone propionate nasal spray (Flonase, and others), which is now available generically.

Every pharmaceutical drug is a dose-dependent poison. This article describes the clinical presentation and treatment of some dangerous overdoses commonly reported in adults.

Production of erythropoietin, a glycoprotein hormone secreted mainly by the kidney, is often low in patients with chronic renal failure (JW Eschbach, Kidney Int, 35:134, 1989). The US Food and Drug Administration recently approved marketing of epoetin alfa (Epogen - Amgen), a recombinant human erythropoietin, for treatment of anemia in such patients. Epoetin is commercially available in Europe as Eprex (Ortho), and Eprex is available from Ortho in the USA on an investigational basis for treatment of anemia related to AIDS. Epogen and Eprex are chemically...

A live attenuated varicella vaccine (Varivax - Merck) has been approved for marketing by the US Food and Drug Administration. The Oka/Merck strain used in the vaccine is attenuated by passage in human and embryonic guinea pig cell cultures.

Cerivastatin (Baycol - Bayer), a new HMG-CoA reductase inhibitor (or "statin"), has been approved by the FDA for treatment of hypercholesterolemia. Cerivastatin is the sodium salt of a synthetic fluorophenyl pyridinyl-substituted heptanoic acid.

Dofetilide (Tikosyn - Pfizer), a new methanesulfonamide antiarrhythmic drug, has recently been marketed for oral treatment of atrial fibrillation and flutter.

Lopinavir/ritonavir is the first fixed-dose combination of protease inhibitors approved by the FDA for the treatment of HIV infection. It is being marketed for use with other drugs in adults and children more than six months old. Lopinavir is a new drug available only in this combination. Ritonavir is often used with other protease inhibitors to raise their plasma concentrations.

The FDA has approved a nebulized suspension of the corticosteroid budesonide for maintenance treatment of persistent asthma in children one to eight years old.

Bivalirudin is being promoted as an intravenous (IV) anticoagulant that can be used instead of heparin in patients with unstable angina undergoing coronary angioplasty.