The FDA has approved the pyrimidine analog uridine triacetate (Vistogard – Wellstat Therapeutics) for emergency treatment of a fluorouracil (5-FU) or capecitabine (Xeloda, and generics) overdose or severe toxicity that occurs within 96 hours following administration of one of these drugs. Fluorouracil is a cytotoxic antimetabolite used to treat breast, colorectal, and other cancers; capecitabine is an oral prodrug of fluorouracil.Uridine triacetate, a prodrug, is deacetylated to uridine after oral administration. Excess circulating uridine is converted into uridine triphosphate, which...

Femlyv (Millicent), an orally disintegrating tablet containing ethinyl estradiol and norethindrone acetate, has been approved by the FDA for prevention of pregnancy in females with a body mass index (BMI) ≤35 kg/m². It is the first hormonal contraceptive to become available in an orally disintegrating tablet formulation. Traditional oral and chewable tablets containing ethinyl estradiol and norethindrone acetate in a wide range of doses, including those found in Femlyv, have been available in the US for years.

Antiretroviral therapy is recommended for all HIV-infected patients, both to reduce the risk of disease progression and to prevent transmission of the virus to others. Various guidelines for treatment of HIV infection are available.

Terbinafine 1% cream (Lamisil - Sandoz), an allylamine synthetic antifungal drug chemically related to naftifine (Naftin - Medical Letter, 30:98, 1988), is now available in the USA for topical treatment of tinea pedis, tinea cruris, and tinea corporis infections. An oral formulation is available in Europe and is under investigation here.

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.

The antiestrogen toremifene (Fareston - Schering) and the selective aromatase inhibitor letrozole (Femara - Novartis) have been approved by the FDA for treatment of advanced breast cancer in postmenopausal women.

Cilostazol, a phosphodiesterase III inhibitor that has been used in Japan since 1988, has been approved by the FDA for treatment on intermittent claudication due to occlusive peripheral arterial disease.

Two cholesterol-lowering margarines have been marketed in the USA.

Balsalazide disodium (Colazal), a prodrug of mesalamine, was marketed in the US this year for oral treatment of mildly to moderately active ulcerative colitis. Oral formulations of mesalamine have been available in the US for nine years for treatment and maintenance of remissions and olsalazine, which is a dimer of mesalamine, is marketed for maintenance of remissions but not for treatment. Balsalazide has been available in Europe for four years.

Enfuvirtide (T-20; Fuzeon Trimeris/Roche), the first in a new class of HIV drugs known as fusion inhibitors, has received accelerated approval from the FDA for use with other antiretrovirals in adults and children with viral replication despite ongoing antiretroviral therapy. This review describes the mechanism of action and pharmacokinetics of the new drug, and outlines the results of the 2 clinical studies that led to its approval. Sections on adverse effects, development of resistance, and dosage and cost are also included. The review concludes with an overall assessment of the...