Rotarix, an oral live-attenuated rotavirus vaccine, has been approved by the FDA for prevention of rotavirus gastroenteritis in infants and children. Rota-Shield was withdrawn from the market because of an association with intussusception. RotaTeq, an oral live, human-bovine reassortant rotavirus vaccine, is recommended by the American Academy of Pediatrics as a routine immunization.

The FDA has approved the steroid prasterone (Intrarosa – Endoceutics) for intravaginal treatment of postmenopausal women with moderate-to-severe dyspareunia due to vulvovaginal atrophy (VVA). Also called dehydroepiandrosterone (DHEA), prasterone is produced in the adrenal glands, gonads, and brain and converted intracellularly into active metabolites of estrogens and androgens. DHEA has been available over the counter for years as an oral dietary supplement claimed to benefit sexual, cardiovascular, and neuropsychiatric dysfunction.

More antibiotics are prescribed for treatment of acute otitis media (AOM) than for any other infection in young children. Children with AOM typically present with otalgia, fever, and bulging and erythema of the tympanic membrane.

The FDA has approved the intravenously administered synthetic vasopressin analog terlipressin (Terlivaz – Mallinckrodt) to improve kidney function in adults with hepatorenal syndrome (HRS) and a rapid decline in kidney function. Terlipressin is the first drug to be approved for this indication in the US; it has been available in Europe and elsewhere for year

Liraglutide (Victoza – Novo Nordisk), a glucagon-like peptide-1 (GLP-1) receptor agonist given by subcutaneous injection, has been approved by the FDA for treatment of patients with type 2 diabetes. It can be used alone or in addition to oral antidiabetic drugs such as metformin (Glucophage, and others) or glimepiride (Amaryl, and others). Liraglutide is not recommended for first-line therapy and is not approved for use with insulin.

Romiplostim (Nplate - Amgen), a recombinant fusion protein injected subcutaneously, and eltrombopag (Promacta - GlaxoSmithKline), a non-peptide taken orally, have been approved by the FDA for treatment of chronic immune thrombocytopenic purpura (ITP) refractory to corticosteroids, immunoglobulins and/or splenectomy.

A new formulation of the H1-antihistamine azelastine hydrochloride 0.1% nasal spray (Astepro - Meda) has been approved by the FDA for treatment of seasonal allergic rhinitis (SAR) in patients ≥12 years old and is being heavily advertised to the public on radio, television and the Internet. All azelastine products require a prescription.

In recent years, selective destruction of cardiac tissue by radiofrequency energy has become a routine procedure for treatment of some types of cardiac arrhythmias, particularly supraventricular tachycardias (MM Scheinman, Pacing Clin Electrophysiol, 18:1474, 1995).

Terbinafine (Lamisil - Sandoz), an allylamine synthetic antifungal, previously available in the USA in a topical formulation (Medical Letter, 35:76, 1993) has now been marketed for oral use in the treatment of fungal nail infections caused by dermatophytes. Oral terbinafine has been available in Europe since 1992.

Esomeprazole magnesium (Nexium - AstraZeneca), the S-isomer of omeprazole (Prilosec), is the fifth benzimidazole proton pump inhibitor to become available in the United States. Omeprazole, which was the first, is going off patent this year.