The FDA has required the manufacturer of the secondgeneration antipsychotic quetiapine (Seroquel) to add a warning to the labeling saying that use of the drug should be avoided in combination with other drugs that prolong the electrocardiographic QTc interval (Table 1). The warning is based only on postmarketing reports of QT-interval prolongation in patients who overdosed on the drug, had concomitant illness, or were taking other drugs known to cause electrolyte imbalances or increase the QT interval. QT prolongation can lead to torsades de pointes, a potentially fatal cardiac...

Cilostazol, a phosphodiesterase III inhibitor that has been used in Japan since 1988, has been approved by the FDA for treatment on intermittent claudication due to occlusive peripheral arterial disease.

The FDA has approved a 4% aerosol foam formulation of minocycline (Amzeeq – Foamix) for topical treatment of inflammatory lesions of non-nodular moderate to severe acne in patients ≥9 years old. It is the first topical tetracycline formulation to be approved for use in patients with acne. Oral minocycline (Minocin, Solodyn, and generics) is

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.

Methadone, an opioid agonist that can be taken orally, has been used for maintenance treatment for many years in the USA (DM Novick et al, Drug Alcohol Depend, 33:235, 1993). Last year, the US Food and Drug Administration approved the distribution and use of L-alpha-acetyl-methadol (LAAM; ORLAAM - Bio Development Corporation, McLean, VA), a long-acting congener of methadone. LAAM, like methadone, will be available for this indication only through federal and state-regulated treatment programs.

Sibutramine hydrochlorid monohydreate (Meridia - Knoll), which is structurally related to amphetamine, has been approved by the FDA for treatment of obesity. It is classified by the Drug Enforcement Agency (DEA) as a schedule IV controlled substance.

Augmentin XR (GlaxoSmithKline), an oral extended-release combination of amoxicillin and the beta-lactamase inhibitor clavulanic acid, is now being promoted for treatment of acute bacterial sinusitis and community-acquired pneumonia. Augmentin XR contains a higher dose of amoxicillin than Augmentin.

A topical formulation of 0.75% metronidazole gel (MetroGel - Curatek), an antibacterial, antiparasitic agent, was recently approved by the US Food and Drug Administration for treatment of rosacea.

Quetiapine (Seroquel - Zeneca), a dibenzothiazepine derivative, has been approved by the FDA for treatment of schizophrenia and other psychotic disorders. It is a new addition to the 'atypical' antipsychotics, which include olanzapine (Zyprexa - Medical Letter, 39:5, 1997), risperidone (Risperdal) and clozapine (Clozaril). Atypical antipsychotic drugs generally are less likely to cause extrapyramidal symptoms than older drugs such as haloperidol (Haldol, and others) or the phenothiazines.

Two new fluoroquinolone solutions, moxifloxacin 0.5% (Vigamox - Alcon) and gatifloxacin 0.3% (Zymar - Allergan) are now available in the US for ophthalmic use in treatment of bacterial conjunctivitis.