Intravenous formulations of immune globulin (IVIG) have been available for more than ten years for treatment of immune deficiency (Medical Letter, 24:81, 1982). Seven preparations are now licensed in the USA, with additional indications for their use.

Nitazoxanide (Alinia - Romark Labs), a new antiparasitic drug, has been approved by the FDA in a liquid formulation for treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia in children 1 to 11 years old. It is the first drug approved for treatment of cryptosporidiosis and the first to become available as a liquid for treatment of giardiasis. The FDA is reviewing a tablet formulation of nitazoxanide for use in adults.

The FDA has approved an intranasal gel formulation of testosterone (Natesto – Trimel/Endo) for replacement therapy in men with hypogonadism. Packaged in a metered-dose pump, Natesto is the first intranasal testosterone to become available in the US. Like other testosterone products, it is classified as a schedule III controlled substance. The FDA recently cautioned against using testosterone to treat low testosterone levels solely due to aging because the benefits and safety of such use have not been established, and there is a possible increased risk of myocardial infarction...

The FDA has approved isavuconazonium sulfate (Cresemba – Astellas) for intravenous and oral treatment of invasive aspergillosis and invasive mucormycosis in adults. Isavuconazonium sulfate is a prodrug of isavuconazole, a broad-spectrum triazole antifungal.

Fosfomycin, a broad-spectrum antibiotic used parenterally in Europe for many years, has been approved by the US Food and Drug Administration (FDA) as fosfomycin tromethamine (Monurol - Forest) for single-dose oral treatment of uncomplicated urinary tract infections in women.

Recently updated guidelines from the American Thoracic Society (ATS) and the Infectious Diseases Society of America (IDSA) address the use of corticosteroids as an adjunct to antimicrobials for treatment of community-acquired pneumonia (CAP).

The text that follows reviews some common bacterial infections and their empiric treatment pending the results of culture and susceptibility testing. The recommendations made here are based on the results of susceptibility studies, clinical trials, and the opinions of Medical Letter reviewers. Tables 1 and 2 list the usual dosages of antibacterial drugs.

The US Food and Drug Administration (FDA) has approved 'early access' use of riluzole (Rilutek - Rh ne-Poulenc Rorer) for treatment of amyotrophic lateral sclerosis (ALS). is the first drug to become available for treatment of this condition. The premarketing supply is limited; the manufacturer (1-800-798-7425) has enough on hand to treat 3,000 of the 25,000 patients with the disease in the USA, and those 3,000 have already been selected through a lottery. Similar arrangements have been made in several European countries. Riluzole is not available commercially in any country.

The FDA has approved oritavancin (Orbactiv – The Medicines Company), a long-acting lipoglycopeptide antibiotic given as a single intravenous (IV) dose, for treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria in adults. It is the third lipoglycopeptide antibiotic to be marketed in the US; telavancin (Vibativ) and dalbavancin (Dalvance) were approved earlier.

Tildrakizumab-asmn (Ilumya – Sun), an interleukin (IL)-23 antagonist, has been approved by the FDA for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tildrakizumab is the second selective IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) was the first.