Fentanyl, a synthetic opioid previously available for parenteral use in anesthesia (Sublimaze), has now been marketed in a controlled-release transdermal formulation (Duragesic - Janssen) for use in patients with chronic pain severe enough to require opioid analgesia. It is not recommended for treatment of postoperative pain because of the drug's slow onset and prolonged duration of action.

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).

Implanted devices that monitor cardiac rhythm and can recognize and treat ventricular tachycardia or ventricular fibrillation are now widely used in the USA and other countries. Implantable cardioverter/defibrillators (ICDs) marketed here include the Ventak P and PRX (Cardiac Pacemakers, Inc., St. Paul, MN), the PCD (Medtronic, Minneapolis, MN), and the Cadence (Ventritex, Sunnyvale, CA) (JG Porterfield et al, Am J Cardiol, 72:301, 1993).

Metformin (Glucophage - Bristol-Myers Squibb), a hypoglycemic agent, was recently marketed in the USA for oral treatment of patients with non-insulin-dependent diabetes mellitus (NIDDM) not adequately controlled by diet alone. Previously marketed in more than ninety countries, including Canada, metformin (dimethylbiguanide) is chemically related to phenformin (phenylethylbiguanide), which was withdrawn from the US market in 1976 because it caused a high incidence of lactic acidosis. In approving metformin, the US Food and Drug Administration stipulated that a post-marketing controlled...

Neotame (Neotame - NutraSweet Co.), an analog of aspartame (NutraSweet, and others), has been approved by the FDA for use as a nonnutritive sweetener and "flavor enhancer" in foods and beverages. Other non-caloric sweeteners available in the US include saccharin (Sweet'N Low, and others), acesulfame potassium (Sunette - Medical Letter, 1988; 30:116) and sucralose (Splenda - Medical Letter, 1998; 40:67). Neotame was approved for use in Australia and New Zealand in 2001.

High doses of beta carotene, vitamin C, vitamin E and zinc oxide are now being promoted to the general public to "preserve eye health" (Ocuvite PreserVision), "promote retinal and visual health" (VisiVite) and "preserve healthy vision" (ICaps). Internet advertisements for these products all refer to a clinical trial, the Age-Related Eye Disease Study (AREDS), which was conducted in patients with age-related macular degeneration (AMD).

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

The combination of pemetrexed (Alimta - Lilly) and cisplatin is the first chemotherapy regimen approved by the FDA for treatment of malignant pleural mesothelioma. This uncommon malignancy, which has been linked to asbestos exposure, was previously considered unresponsive to chemotherapy, with a median survival of 6-8 months from diagnosis (VW Rusch, J Clin Oncol 2003; 21:2629).

The antisense oligonucleotide viltolarsen (Viltepso – NS Pharma) has received accelerated approval from the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients who have mutations of the dystrophin gene that are amenable to exon 53 skipping (DMD-53). It is the second drug to be approved for this indication; the antisense oligonucleotide golodirsen (Vyondys 53) was approved in 2019.

Brella Sweat Control Patch (Candesant Biomedical), a sodium-containing transdermal patch, has been cleared by the FDA for in-office treatment of primary axillary hyperhidrosis in adults. It is the first patch to be approved in the US for this indication.