The FDA has approved a fixed-dose combination of the long-acting anticholinergic glycopyrrolate and the long-acting beta2-adrenergic agonist (LABA) formoterol (Bevespi Aerosphere – AstraZeneca) for long-term maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Glycopyrrolate/formoterol is the fourth long-acting anticholinergic/LABA combination to be approved in the US, but the first to become available in a metered-dose inhaler. Glycopyrrolate/indacaterol (Utibron Neohaler), umeclidinium/vilanterol (Anoro Ellipta), and tiotropium/olodaterol (Stiolto...

The FDA has expanded its Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use in children as young as 6 months old. The Pfizer vaccine was previously authorized for use in persons ≥5 years old, and the Moderna vaccine was authorized for use in adults ≥18 years old.

Bexagliflozin (Brenzavvy – TheracosBio), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved by the FDA to improve glycemic control in adults with type 2 diabetes. It is the fifth SGLT2 inhibitor to be approved in the US for this indication (see Table 4).

Trimetrexate glucuronate (Parke-Davis), an investigational drug, is now available in the USA from the National Institute of Allergy and Infectious Diseases (NIAID) for treatment of selected AIDS patients with Pneumocystis carinii pneumonia (PCP). For this indication, trimetrexate is always used concurrently with leucovorin (Wellcovorin; and others).

In the first six months of 1989, more than 7,000 cases of measles were reported to the US Centers for Disease Control (CDC), a sharp increase over previous years (Morbid Mortal Weekly Rep, 33:456, July 7, 1989). Many of these cases occurred in children and college students who had previously been vaccinated against the disease. Practitioners have asked, therefore, whether their previously immunized young patients should receive a second (or, in some cases, third) immunization against measles.

The gram-positive bacillus Clostridium difficile is the most common identifiable cause of antibiotic-associated diarrhea and pseudomembranous colitis (R Fekety in GL Mandell et al, eds, Principles and Practice of Infectious Diseases, 3rd ed, New York:Churchill Livingstone, 1990, page 863). C. difficile colitis usually develops during or soon after antibiotic treatment. Virtually any antimicrobial agent can cause the disorder, but clindamycin, ampicillin and the cephalosporins have been implicated most frequently. Pseudomembranous colitis was recently reported in five patients who had ...

The Norplant System (Wyeth-Ayerst) for subdermal delivery of the synthetic progestin levonorgestrel was recently approved by the US Food and Drug Administration for use as a long-term contraceptive.

BCG Live (TheraCys - Connaught) and BCG Vaccine U.S.P. (TiceBCG - Organon), freeze-dried suspensions of an attenuated strain of Mycobacterium bovis, were recently approved by the US Food and Drug Administration for intravesical treatment of primary or relapsed carcinoma in situ of the bladder, with or without associated papillary tumors. BCG is not recommended for treatment of papillary tumors occurring alone.

Many drugs, mostly imidazole derivatives, are marketed in the USA for topical treatment of vulvovaginal candidiasis, and a few are now available without a prescription.

Fludarabine phosphate (Fludara - Berlex), an analog of vidarabine (Vira-A), was recently approved by the U.S. Food and Drug Administration for treatment of patients with refractory chronic lymphocytic leukemia (CLL). The drug has not yet been marketed but is still available, as it has been for two years, through the National Cancer Institute.