The FDA has approved another fixed combination of the antibiotic clindamycin phosphate and the oxidizing agent benzoyl peroxide (Onexton Gel 1.2%/3.75% – Valeant) for topical treatment of acne in patients ≥12 years old. Topical products containing the same drugs have been available for many years. Onexton Gel contains a new strength of benzoyl peroxide.

Bacterial infections of the conjunctivae are usually self-limited, but topical antimicrobial therapy can be helpful. A solution of trimethoprim sulfate 0.1% with polymyxin B sulfate 10,000 units/ml (Polytrim - Burroughs Wellcome, distributed by Allergan) was recently marketed in the USA for treatment of superficial ocular bacterial infections.

Dirithromycin (Dynabac - manufactured by Lilly, distributed by Bock), an oral macrolide antibiotic chemically similar to erythromycin, clarithromycin (Biaxin) and azithromycin (Zithromax), has been approved for marketing by the US Food and Drug Administration (FDA).

The FDA has approved a fixed-dose combination of omeprazole, amoxicillin, and rifabutin (Talicia – RedHill) for treatment of Helicobacter pylori infection in adults. Talicia is the first rifabutin-based product to be approved for this indication.

Lansoprazole (Prevacid -TAP), a proton pump inhibitor similar to omeprazole (Prilosec - Medical Letter, 32:19, 1990), has been approved by the US Food and Drug Administration for short-term treatment of active duodenal ulcer and erosive reflux esophagitis and for long-term treatment of chronic hypersecretory conditions, including the Zollinger-Ellison syndrome.

Cefepime hydrochloride (Maxipime - Bristol-Myers Squibb), a new 'fourth-generation' cephalosporin, has been approved by the US Food and Drug Administration (FDA) for parenteral treatment of urinary tract infections and skin and skin-structure infections due to susceptible pathogens, and for moderate to severe pneunmonia caused by Streptococcus pneumoniae (pneumococci), Pseudomonas aeruginosa, Enterobacter or Klebsiella pneumoniae.

Grepafloxacin (Raxar - Glaxo Wellcome), a once-daily oral fluoroquinolone, is now being marketed for treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, uncomplicated gonorrhea, and nongonococcal urethritis and cervicitis.

Quinupristin and dalfopristin, two streptogramin antibacterials marketed in a 30:70 combination as Synercid, have received accelerated approval from the FDA for intravenous treatment of bacteremia and life-threatening infection....

The FDA has approved Twyneo (Galderma), a cream containing the retinoid tretinoin and the oxidizing agent benzoyl peroxide, for once-daily topical treatment of acne in patients ≥9 years old.

The FDA has announced that it is requiring changes in the labeling of the macrolide antibiotic azithromycin (Zithromax, Zmax) to warn about the risk of QT prolongation and cardiac arrhythmias.1 The new warnings are based on a retrospective study in The New England Journal of Medicine (reviewed previously in The Medical Letter2), which found that among patients who received 347,795 prescriptions for azithromycin, there were 29 cardiovascular deaths, a significantly higher rate than the 42 that occurred among patients who received 1,348,672 prescriptions for amoxicillin (which does not prolong...