Fondaparinux (Arixtra - Organon Sanofi-Synthelabo), a synthetic analog of heparin, has been approved by the FDA for prevention of deep vein thrombosis (DVT) after hip fracture surgery or knee or hip replacement.

The FDA has approved a new low-dose estrogen patch (Menostar - Berlex) for prevention of osteoporosis in postmenopausal women. Unlike other estrogen patches, it is not approved for treatment of hot flashes or other menopausal symptoms. Promotional material from the manufacturer suggests that this low dose of estrogen could prevent osteoporosis without some of the adverse effects of higher doses.

Entecavir (Baraclude - Bristol-Myers Squibb), a nucleoside analog, has been approved by the FDA for treatment of adults with active chronic hepatitis B virus (HBV) infection.

The 2006 Medical Letter article on the then-new varicella-zoster vaccine concluded that Zostavax appears to be safe and effective in protecting patients ≥60 years old against herpes zoster and postherpetic neuralgia, especially in reducing the severity and duration of the disease.1 Some new information has recently become available.CLINICAL STUDIES — A Veterans Administration randomized, double-blind trial enrolled more than 38,000 patients ≥60 years old and followed them for a mean of 3.4 years after administration of Zostavax or placebo. Since the efficacy of the vaccine had been...

In recent years, many women have become concerned about the safety of pharmaceutical replacement hormones for treatment of menopausal symptoms. “Bioidentical” hormone preparations, which are not approved by the FDA, are heavily promoted in popular books and on TV as alternatives; these are derivatives of soy or plant extracts, chemically modified to be structurally identical to endogenous hormones. Most FDA-approved single-entity hormones are also derivatives of soy or plant extracts and are structurally identical to hormones produced by the ovary.

The FDA has approved an intravenous (IV) formulation of acetaminophen (Ofirmev – Cadence) for use in patients ≥2 years old for management of pain either as monotherapy (mild to moderate pain) or with an opioid (moderate to severe pain) and for reduction of fever.

The FDA has approved aclidinium bromide (Tudorza Pressair – Forest), an orally-inhaled long-acting anticholinergic, for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).

The FDA has approved dimethyl fumarate (Tecfidera – Biogen Idec), formerly called BG-12, for treatment of relapsing forms of multiple sclerosis (MS). It is the third oral drug to be approved in recent years for this indication.

The FDA has approved tavaborole 5% solution (Kerydin – Anacor Pharmaceuticals) for topical treatment of toenail onychomycosis due to Trichophyton rubrum or Trichophyton mentagrophytes. It is the first oxaborole antifungal drug to be approved for this indication.

The FDA has approved two new long-acting injectable formulations of second-generation antipsychotics for treatment of schizophrenia: aripiprazole lauroxil (Aristada – Alkermes), which is given once every 4-6 weeks, and paliperidone palmitate (Invega Trinza – Janssen), which is given once every 3 months. Once-monthly injectable formulations of aripiprazole (Abilify Maintena) and paliperidone palmitate (Invega Sustenna) were approved earlier.