Telavancin (Vibativ - Astellas and Theravance), a lipoglycopeptide derivative of vancomycin (Vancocin, and others), has received FDA approval for treatment of complicated skin and skin structure infections caused by susceptible gram-positive bacteria in adults.

The FDA has approved Alyftrek (Vertex), an oral fixed-dose combination of the cystic fibrosis transmembrane conductance regulator (CFTR) modulators vanzacaftor, tezacaftor, and deutivacaftor, for once-daily treatment of cystic fibrosis (CF) in patients ≥6 years old who have at least one F508del mutation or another responsive mutation in the CFTR gene. This is the first approval for vanzacaftor and for deutivacaftor, a deuterated form of ivacaftor. Trikafta, a twice-daily oral fixed-dose combination of elexacaftor, tezacaftor, and ivacaftor, is FDA-approved for the same indication...

The FDA has required the manufacturer of eszopiclone (Lunesta – Sunovion), a benzodiazepine receptor agonist approved for the treatment of insomnia, to lower the current recommended starting dose to 1 mg for both men and women because a new study found that an evening dose of 3 mg can impair driving skills, memory, and coordination for more than 11 hours.1 Eszopiclone’s half-life is longer than that of any other drug in its class, which includes zolpidem (Ambien, and generics) and zaleplon (Sonata, and generics).All benzodiazepine receptor agonists may impair performance the next morning,...

First approved in 2000 for termination of pregnancies of ≤49 days' gestation, the indication for the oral antiprogestin mifepristone (Mifeprex, and generics) was expanded in 2016 to include pregnancies of up to 10 weeks' gestation. A single 200-mg oral dose of mifepristone followed 24-48 hours later by a single 800-mcg buccal dose of the prostaglandin analog misoprostol terminates early intrauterine pregnancies in about 95% of women.

Qualaquin, the only formulation of quinine sulfate available in the US, is approved only for treatment of uncomplicated malaria, but most prescriptions for its use are written for treatment or prevention of nocturnal leg cramps. The FDA recently issued a warning about its safety.Between April 2005 and October 2008, 38 cases of serious or life-threatening adverse effects of quinine were reported to the FDA. Twenty-one of these patients had thrombocytopenia and required hospitalization. Two deaths were reported: one from hemolysis and the other from thrombotic thrombocytopenic purpura (TTP)....

Annual vaccination against influenza A and B viruses is recommended in the US for everyone ≥6 months old without a contraindication. Influenza vaccines available in the US for the 2025-2026 season are listed in Table 2.

Varenicline tartrate (Chantix - Pfizer) is now available for oral treatment of tobacco dependence. Some other drugs for this indication are listed in this article.

Soft contact lenses have been in use for more than 20 years. Since the last Medical Letter review (vol. 24, page 109, 1982), new products have been developed, and some problems have emerged.

Finasteride (Proscar - Merck) has now been approved by the US Food and Drug Administration (FDA) for oral treatment of benign prostatic hyperplasia. A 4-aza-steroid, the drug is a specific inhibitor of steroid 5 -reductase, the enzyme that catalyzes conversion of testosterone to dihydrotestosterone. Dihydrotestosterone is required for development and maintenance of prostatic hypertrophy (JS Tenover, Endocrinol Metab Clin North Am, 20:893, 1991).

Loratadine (Claritin - Schering), a new H 1 -receptor antagonist, has been approved by the U.S. Food and Drug Administration for treatment of seasonal allergic rhinitis in patients more than 12 years old. It will compete with older, relatively sedating drugs such as chlorpheniramine (Chlor-Trimeton, and others) and clemastine (Tavist - Medical Letter, 35:9, 1993) and with newer relatively non-sedating agents such as terfenadine (Seldane) and astemizole (Hismanal).