Zonisamide (Zonegran - Elan Pharma), a sulfonamide chemically unrelated to other antiepileptic drugs, has been approved by the FDA for adjunctive use in adults with partial seizures. Zonisamide has been available in Japan for more than 10 years.

Tenecteplase, a recombinant variant of human tissue plasminogen activator, is now available for thrombolysis in patients with acute myocardial infarction.

The number of cough remedies available in the USA continues to multiply, but most products contain the same or similar ingredients in varying combinations. Most acute coughs do not require treatment with drugs, especially in children, and suppression of a productive cough may be harmful.

Nateglinide (Starlix), a new meglitinide oral glucose-lowering agent, has been approved by the FDA.

Insulin Glargine (Lantus) is a new long-acting human insulin analog approved by the FDA for treatment of both type 1 and type 2 diabetes. Synthesized by recombinant DNA technology, it differs from human insulin at position 21 in the A-chain where asparagine is replaced by glycine and at the C-terminus of the B-chain where two arginines are added.

A vaccine to prevent both Hepatitis A and Hepatitis B (Twinrix), previously licensed in Canada and Europe, is now available in the US for adults.

Several recent case reports suggest that oral sildenafil may be effective for treatment of pulmonary arterial hypertension (PAH). Sildenafil is currently marketed as Viagra for treatment of erectile dysfunction (Medical Letter 1998; 40:51).

Modafinil (Provigil - Cephalon; Alertec - Draxis in Canada), first approved by the FDA in 1999 for treatment of excessive daytime sleepiness associated with narcolepsy (Medical Letter 1999; 41:30), has now also been approved for treatment of patients with excessive sleepiness due to obstructive sleep apnea/hypopnea syndrome (OSAHS) or shift work sleep disorder (SWSD) (DSM-IV, text revision, Washington, DC: American Psychiatric Association, 2000, page 622).

Tiotropium bromide inhalation powder (Spiriva HandiHaler - Boehringer Ingelheim), a long-acting anticholinergic agent, has been approved by the FDA for once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Available in Europe since 2002, it is the first long-acting inhaled anticholinergic drug for treatment of COPD. Ipratropium bromide (Atrovent), an anticholinergic used four times daily, has been available in the US for many years.

Imiquimod cream 5% (Aldara - 3M), an immune modifier previously approved for treatment of genital and perianal warts (Medical Letter 1997; 39:118), has now been approved by the FDA for treatment of actinic keratoses (AKs) on the face or scalp, and may also be approved soon for treatment of basal cell carcinoma. It produces apoptosis in malignant, but not normal, human keratinocytes (M Sch÷n et al, J Natl Cancer Inst 2003; 95:1138).