The FDA has approved mannitol powder for oral inhalation (Bronchitol – Chiesi) as add-on maintenance treatment to improve pulmonary function in adults with cystic fibrosis (CF). This product has been available in Europe for the same indication since 2012. Another formulation of mannitol inhalation powder (Aridol) is approved in the US for assessment of bronchial hyperresponsiveness.

Ramelteon (Rozerem - Takeda), a melatonin receptor agonist, has been approved by the FDA for treatment of insomnia characterized by difficulty falling asleep. Unlike all other prescription hypnotics, which are classified as schedule IV drugs, ramelteon is not a controlled substance.

Patients with seasonal allergies often experience nasal itching and congestion, sneezing, rhinorrhea, and itchy, watery eyes. Oral, intranasal, and ophthalmic preparations are widely available over the counter (OTC) for relief of symptoms. Prescription products for management of allergic rhinitis and allergic conjunctivitis are reviewed separately.

Naftifine hydrochloride 1% cream (Naftin - Herbert Laboratories), was recently approved by the US Food and Drug Administration (FDA) for topical treatment of tinea cruris and tinea corporis. It is available only by prescription.

Bupropion (Wellbutrin - Burroughs Wellcome) was recently marketed in the USA for treatment of depression. First approved by the Food and Drug Administration in late 1985, the drug was withdrawn from the market in early 1986 because of a high incidence of seizures in one study.

Sertraline (Zoloft - Roerig), a serotonin reuptake inhibitor, was recently approved for marketing by the US Food and Drug Administration for treatment of depression. Another serotonin reuptake inhibitor, fluoxetine (Prozac), is prescribed more frequently in the USA than any other antidepressant (Medical Letter, 32:83, 1990).

Sotalol (hydrochloride (Betapace -Berlex; Sotacor -Bristol Laboratories of Canada), an antiarrhythmic drug that prolongs repolarization (Class III) and also has beta-adrenergic-blocking activity (Class II), was recently approved by the US Food and Drug Administration (FDA) for oral treatment of life-threatening ventricular arrhythmias.

Minoxidil 2% topical solution (Rogaine - Upjohn) has been available in the USA since 1988 for treatment of androgenetic alopecia (Medical Letter, 29:87, 1987). Although available only by prescription, it is advertised on television to the general public.

An intravenous formulation of amiodarone (Cordarone IV -Wyeth-Ayerst) has been approved by the US Food and Drug Administration (FDA) for treatment and prophylaxis of recurrent ventricular fibrillation (VF) or hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy.

Olanzapine (Zyprexa - Lilly), a thienobenzodiazepine that structurally resembles and binds to many of the same receptors as clozapine (Clozaril), is now available in the USA for treatment of schizophrenia and other psychotic disorders.