The amyloid beta-directed monoclonal antibody lecanemab-irmb (Leqembi – Eisai/Biogen) has now been approved by the FDA for once-monthly use for treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia. It was previously approved only for administration once every 2 weeks. Now, lecanemab can be given every 4 weeks after an 18-month initiation phase of biweekly administration.

Mitoxantrone (Novantrone - Lederle), a synthetic anthracene related to the anthracyclines doxorubicin (Adriamycin) and daunorubicin (Cerubidine), has now been marketed in the USA to be used in combination with other drugs for initial treatment of acute nonlymphocytic leukemia in adults.

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.

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.

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.

Efalizumab (Raptiva - Genentech/XOMA), a humanized monoclonal antibody that inhibits T-cell activation, has been approved by the FDA for treatment of adults with moderate to severe chronic plaque psoriasis.

The FDA has reported that 5106 elderly patients with dementia treated with atypical (second generation) antipsychotics in 17 randomized controlled trials had a higher mortality rate (4.5% vs. 2.6%) than those receiving placebo. Most of the deaths were due to cardiovascular and infectious causes (such as pneumonia). The drugs used in the trials were aripiprazole (Abilify), olanzapine (Zyprexa), quetiapine (Seroquel), and risperidone (Risperdal). As the increase in mortality was considered a class effect, the FDA advisory also included ziprasidone (Geodon), clozapine (Clozaril) and the...

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 ticagrelor (Brilinta – AstraZeneca), an oral antiplatelet drug, for use with low-dose aspirin to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (ACS). It will compete with clopidogrel (Plavix) and prasugrel (Effient) for such use. Clopidogrel is expected to become available generically in the US within the next few months.

Atrial fibrillation increases the risk of thromboembolic stroke. Anticoagulant therapy can reduce this risk and is recommended for patients with atrial fibrillation and one or more of the following: congestive heart failure, hypertension, age ≥75 years, diabetes, or prior stroke or transient ischemic attack (CHADS₂ score ≥1).