hydrochloride (Ticlid - Syntex), a platelet aggregation inhibitor that has been available in Europe for more than a decade, was recently approved by the U.S. Food and Drug Administration to decrease the risk of thrombotic stroke in men and women who have had premonitory signs of stroke or have had a completed thrombotic stroke. The manufacturer is promoting the drug for patients intolerant to aspirin or with conditions for which aspirin has not been approved (previous thrombotic stroke; transient ischemic attacks in women). The drug has also been used for prevention of myocardial ...

Fluvastatin (Lescol - Sandoz), an HMG-CoA reductase inhibitor, was recently marketed in the USA for treatment of hypercholesterolemia. A synthetic mevalonolactone derivative, it is chemically distinct from previously available drugs in this class.

Risedronate (Actonel - Procter & Gamble), a pyridinyl bisphosphonate, has been approved by the FDA for oral treatment of Paget's disease of bone. Characterized by excessive bone resorption, bony deformity, disorganized bone remodeling and structural weakness, Paget's disease occurs in up to 3% of people older than 55 in Europe and North America (PD Delmas and PJ Meunier, N Engl J Med, 336:558, 1997).

The FDA has approved baloxavir marboxil (Xofluza – Shionogi/Genentech), the first polymerase acidic (PA) endonuclease inhibitor, for single-dose, oral treatment of acute uncomplicated influenza in patients ≥12 years old. Baloxavir is the first drug with a new mechanism of action to be approved for treatment of influenza in almost 20 years.

The FDA has approved Suflave (Sebela/Braintree), a low-volume polyethylene glycol (PEG)- and sulfate-based product for cleansing of the colon prior to colonoscopy in adults. Other oral colonoscopy preparations available in the US are listed in Table 2. Suflave is marketed as tasting better than other products.

Olsalazine sodium (Dipentum - Pharmacia), a dimer (two molecules linked by an azo bond) of 5-aminosalicylic acid, was recently approved by the US Food and Drug Administration for oral use to maintain remission of ulcerative colitis in adult patients who cannot tolerate sulfasalazine (Azulfidine; and others).

Recently pharmaceutical manufacturers have marketed a stereoisomer of a successful drug nearing patent expiration as a new drug. Examples, such as esomeprazole (Nexium) , levalbuterol (Xopenex), escitalopram (Lexapro) and dexmethylphenidate

Teniposide (ten i poe' side; VM 26; Vumon - Bristol), an anticancer drug that has been under investigation in the USA for 20 years, has now been approved for use in combination induction treatment of refractory acute lymphoblastic leukemia (ALL) in children. A semisynthetic derivative of podophyllotoxin, teniposide is chemically related to etoposide (VePesid - Medical Letter, 26:48, 1984).

Astemizole (Hismanal - Janssen), a new antihistamine, was recently marketed in the USA for treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. Like terfenadine (Seldane - Medical Letter, 27:65, 1985), astemizole is claimed to be no more sedating than placebo, but the new drug offers the advantage of a once-daily dosage schedule.

Opdualag (BMS), a fixed-dose combination of two immune checkpoint inhibitors — nivolumab (Opdivo), a programmed death receptor-1 (PD-1) inhibitor, and relatlimab-rmbw, a lymphocyte-activation gene-3 (LAG-3) blocking antibody — has been approved by the FDA for treatment of unresectable or metastatic melanoma in patients ≥12 years old. Relatlimab, which is only available in combination with nivolumab, is the first LAG-3 blocking antibody to become available in the US. Immune checkpoint inhibitors, including the anti-CTLA-4 antibody ipilimumab (Yervoy) and the PD-1 inhibitors...