Clevidipine (Cleviprex - The Medicines Company), a dihydropyridine calcium channel blocker (CCB), has been approved by the FDA for intravenous (IV) use in lowering high blood pressure. It is the second IV CCB to be marketed in the US; nicardipine has been available in an IV formulation (Cardene IV) for more than 10 years. Like IV nicardipine, clevidipine will probably be used mainly for urgent treatment of hypertension in intensive care units, operating rooms and emergency departments.

The FDA has approved edoxaban (Savaysa – Daiichi Sankyo), a once-daily, oral, direct factor Xa inhibitor, for treatment of venous thromoboembolism (VTE) and for prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is the fourth new oral anticoagulant to be approved for VTE and nonvalvular atrial fibrillation.

The FDA has approved mavacamten (Camzyos – MyoKardia/BMS), a modulator of cardiac myosin, to improve functional capacity and symptoms in adults with New York Heart Association (NYHA) class II or III obstructive hypertrophic cardiomyopathy (HCM) who have a baseline left ventricular ejection fraction (LVEF) ≥55%. Mavacamten is the first drug in its class to become available in the US.

The FDA and the manufacturer (Sanofi-Aventis) have warned healthcare professionals that use of dronedarone (Multaq), an analog of amiodarone (Cordarone, and others) approved in 2009 for treatment of atrial fibrillation,1,2 has been associated with "several" cases of severe liver injury and hepatic failure, including two that required liver transplants. Both transplants were in women about 70 years old; one had taken the drug for 4.5 months and the other for 6 months. According to the FDA, 147,000 patients have taken dronedarone.3 A new warning in the package insert recommends monitoring...

Cefixime (Suprax - Lederle), an oral cephalosporin antibiotic, was recently approved for marketing by the US Food and Drug Administration. Claimed to be the first oral third-generation cephalosporin, the new drug is offered for once-a-day treatment of otitis media, pharyngitis, bronchitis and urinary tract infections.

Nabumetone (Relafen - SmithKline Beecham), a new nonsteroidal anti-inflammatory drug (NSAID), has been approved by the US Food and Drug Administration for treatment of rheumatoid arthritis and osteoarthritis. The drug has been available in the United Kingdom since 1987. The manufacturer claims that nabumetone is as effective as other NSAIDs and causes a relatively low incidence of peptic ulcers.

Itraconazole (Sporanox - Janssen), an antifungal triazole, has been approved by the US Food and Drug Administration (FDA) for oral treatment of histoplasmosis and blastomycosis. These two endemic mycoses occur both in normal hosts and in immunocompromised patients, such as those with AIDS (RW Bradsher, Clin Infect Dis, 14:S82, 1992; LJ Wheat, Clin Infect Dis, 14:S91, 1992).

Sparfloxacin (Zagam - Rh ne-Poulenc Rorer) and levofloxacin (Levaquin - Ortho-McNeil) are the newest fluoroquinolone antimicrobials to be approved by the US Food and Drug Administration. Sparfloxacin in a once-daily oral preparation is being marketed for treatment of community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis. Levofloxacin, which is the active stereoisomer of ofloxacin (Floxin), is available for either oral or parenteral use; it is approved for oncedaily treatment of community-acquired pneumonia, acute exacerbations of chronic bronchitis,...

Zonisamide (Zonegran - Elan Pharma), a sulfonamide chemically unrelated to other antiepileptic drugs, has been approved by the FDA for adjunctive use in adults with partial seizures. Zonisamide has been available in Japan for more than 10 years.

Adalimumab (Humira - Abbott), a tumor necrosis factor alpha (TNF-α) inhibitor, has been approved by the FDA for treatment of moderate to severe rheumatoid arthritis (RA). A genetically engineered human IgG1 monoclonal antibody, adalimumab is approved for subcutaneous (SC) injection in adults who have failed at least one disease-modifying anti-rheumatic drug (DMARD), for use either alone or with other DMARDs such as methotrexate (Rheumatrex, and others). Two other TNF-α antagonists, etanercept (Enbrel) and infliximab (Remicade), are already on the market for treatment of RA (Treatment...