The FDA has approved AspireAssist (Aspire Bariatrics), a weight-loss device that permits patients to drain a portion of their stomach contents through a gastrostomy tube into a toilet after each meal. It is approved for long-term use in combination with lifestyle modifications in adults ≥22 years old who have a body mass index (BMI) of 35 to 55 and have not been able to achieve and maintain weight loss with nonsurgical therapy.

The FDA has approved hydrogen peroxide 40% topical solution (Eskata – Aclaris Therapeutics) for treatment of raised seborrheic keratoses (SKs) in adults. It is the first drug to be approved for this indication. (Hydrogen peroxide is available over the counter for topical use as a 3% solution.)

The FDA has approved the GABA_A receptor modulator brexanolone (Zulresso – Sage Therapeutics) for IV treatment of postpartum depression (PPD). Brexanolone is the first drug to be approved by the FDA for this indication.

Emrosi (Journey), an oral, low-dose, biphasic-release formulation of the tetracycline antibiotic minocycline, has been approved by the FDA for once-daily treatment of inflammatory lesions of rosacea (papules and pustules) in adults. Low-dose, biphasic-release doxycycline (Oracea, and generics) has been available for years for treatment of papulopustular rosacea.

Amlodipine (am loe' di peen) besylate (Norvasc - Pfizer), a dihydropyridine calcium-channel blocker, has been approved by the US Food and Drug Administration for once-daily oral treatment of hypertension, chronic stable angina, and vasospastic (Prinzmetal's) angina.

Fenoldopam mesylte (Corlopam - Neurex), a peripheral dopamine-1 (DA₁) agonist, has been approved by the FDA for parenteral use in lowering blood pressure. The manufacturer claims that, unlike other parenteral antihypertensive agents, fenoldopam not only lowers blood pressure but also maintains or improves renal function.

Vardenafil (Levitra -Bayer) is the second oral drug approved by the FDA for treatment of erectile dysfunction. Sildenafil (Viagra - Medical Letter 1998; 40:51), the first oral drug, has been available for 5 years. Pharmacokinetics, effectiveness, adverse effects, dosage and cost of the new drug are reviewed. Whether it offers any benefits over sildenafil is discussed.

Nicardipine (Cardene - Syntex), a dihydropyridine calcium-entry blocker structurally related to nifedipine (Procardia; Adalat), was recently approved by the US Food and Drug Administration for oral treatment of angina and hypertension. Advertisements for the drug claim that nicardipine is more vasoselective; than other calcium-channel blockers and does not depress myocardial contractility.

Sumatriptan (soo ma trip' tan; Imitrex - Glaxo), a serotonin (5-HT) agonist, is now available in Canada and may soon be available in the USA for oral or parenteral treatment of migraine headache. The parenteral formulation is designed for patients to inject themselves subcutaneously. Sumatriptan is not recommended for prophylactic use.

Yttrium-90 ibritumomab tiuxetan (Zevalin -IDEC) was approved by the FDA for treatment of patients with relapsed or refractory low-grade follicular or transformed B-cell non-Hodgkin's lymphoma (NHL), including patients with follicular lymphoma refractory to rituximab (Rituxan -Medical Letter 1998; 40:65). Zevalin is the first radioimmunoconjugate to be approved for treatment of cancer.