Butenafine hydrochloride 1% cream (Mentax - Penederm), a benzylamine antifungal drug similar to the allylamines terbinafine (Lamisil) and naftifine (Naftin), is now available in the USA for topical treatment of tinea pedis, tinea corporis and tinea cruris.

Tiludronate (Skelid - Sanofi), a chloro-4-phenylthiomethylene bisphosphonate, has been approved by the US Food and Drug Administration (FDA) for treatment of Paget's disease of bone. Characterized by excessive bone resorption and disorganized bone remodeling, Paget's disease occurs in up to 3% of people more than 55 years old in Europe and North America (PD Delmas and PJ Meunier, N Engl J Med, 336:558, Feb 20, 1997).

The US Food and Drug Administration (FDA) has approved use of recombinant human interleukin 11 (rhIL-11; oprelvekin; Neumega - Genetics Institute) to increase platelet counts and decrease the need for platelet transfusions in patients with severe thrombocytopenia caused by chemotherapy for nonmyeloid malignancies.

An intranasal spray formulation of the topical corticosteroid mometasone furoate, marketed for treatment of seasonal and perennial allergic rhinitis, has been advertised on television directly to the public.

A new needle-free system (cool.click) has been approved by the FDA for subcutaneous delivery of Saizen (recombinant somatotropin - Serono). Somatotropin is used for long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. Children with growth hormone deficiency require injections daily or several times weekly for many years.

With the coming of spring, direct-to-consumer (DTC) advertisements in newspapers, in magazines and on television are urging people with seasonal allergies to ask their doctors about one or another of the newer, non-sedating antihistamines.

Anakinra (Kineret - Amgen), an interleuken-1 (IL-1) receptor antagonist, has been approved by the FDA for treatment of moderately to severly active rheumatoid arthritis in adults who have failed at least one disease-modifying anti-rheumatic drug(DMARD) such as methotrexate (Medical Letter 2000; 24:57).

The FDA has approved a new low-dose formulation of the tricyclic antidepressant doxepin (Silenor – Somaxon) for treatment of insomnia associated with sleep maintenance. The manufacturer claims that this dose retains the hypnotic effect of doxepin, without typical tricyclic adverse effects. Doxepin is available generically in higher-strength capsules and in a liquid formulation.

The FDA has approved Quartette (Teva), an extended-cycle combination oral contraceptive containing increasing doses of the estrogen ethinyl estradiol (EE) combined with the progestin levonorgestrel (LNG). The rationale is that a gradual increase in the EE dose may reduce unscheduled bleeding or spotting, a common adverse effect of extended-cycle oral contraceptives.

Aducanumab-avwa (Aduhelm – Biogen/Eisai), an IV amyloid beta-directed monoclonal antibody, has received accelerated approval from the FDA for treatment of Alzheimer's disease. The approval was based on the surrogate endpoint of reduction in amyloid beta plaques in the brain. The manufacturer is required to conduct an additional randomized controlled trial to establish that reducing amyloid beta plaques with aducanumab improves clinical outcomes in patients with Alzheimer's disease.