Reteplase (Retavase - Boehringer Mannheim), a recombinant protein derivative of human tissue plasminogen activator (t-PA), has been marketed in the USA for thrombolysis in patients with acute myocardial infarction.

The FDA has approved an inhalation powder formulation of loxapine (Adasuve – Teva), a first-generation antipsychotic long available in an oral formulation, for treatment of acute agitation related to schizophrenia or bipolar I disorder in adults. Adasuve is the first inhaled drug to be approved for this indication.

The FDA has approved an oral solution of the nonselective beta-adrenergic blocker propranolol (Hemangeol – Pierre Fabre) for treatment of proliferating infantile hemangiomas.

The FDA has approved an over-the-counter (OTC) liquid-filled capsule formulation of aspirin (Vazalore – PLx Pharma). The manufacturer has been heavily promoting Vazalore with claims of fast, predictable absorption and antiplatelet activity and improved gastrointestinal safety compared to existing OTC aspirin formulations.

The FDA has approved Zunveyl (Alpha Cognition), a delayed-release formulation of the prodrug benzgalantamine, for treatment of mild to moderate dementia of Alzheimer's disease (AD). Immediate- and extended-release formulations of the acetylcholinesterase inhibitor galantamine have been available in the US for years for treatment of AD.

Three benzodiazepines and 16 other compounds are marketed in the USA for treatment of insomnia. Many authorities believe that insomnia is overdiagnosed and overtreated (MK Erman, ed, Sleep Disorders, Psychiatr Clin North Am, Volume 10, Dec 1987).

Flecainide (Tambocor -3M Pharmaceuticals), first introduced in 1985 for treatment of ventricular arrhythmias, was recently approved by the US Food and Drug Administration for oral use to prevent supraventricular arrhythmias. The indications for using flecainide to treat ventricular arrhythmias were limited after a controlled trial found that post-myocardial infarction patients with asymptomatic ventricular arrhythmias who took the drug had twice as high a mortality rate as patients who took placebo (DS Echt et al, N Engl Med, 324:781, 1991).

Fentanyl, a synthetic opioid previously available for parenteral use in anesthesia (Sublimaze, and others) and in a transdermal patch for chronic pain (Duragesic - Medical Letter, 34:97, 1992), has now also been marketed as a raspberry-colored lozenge on a plastic handle (Fentanyl Oralet - Abbott), which resembles a lollipop. The new formulation will probably be promoted mainly for premedication of children before anesthesia, but has also been approved by the US Food and Drug Administration (FDA) for preanesthetic use in adults and for use in anesthesia or 'monitored anesthesia care' in...

Clopidogrel bisulfate (Plavix - Bristol-Myers Squibb/Sanofi), a new thienopyridine antiplatelet agent similar to ticlopidine (Ticlid - Medical Letter, 34:65, 1992), has been approved by the US Food and Drug Administration (FDA) for secondary prevention of myocardial infarction, stroke and other vascular events.

0.5% malathion in 78% isopropanol was recently approved by the FDA for treatment of head lice.