Fexofenadine (fex oh fen' a deen) hydrochloride (Allegra - Hoechst Marion Roussel) has been approved by the US Food and Drug Administration for treatment of seasonal allergic rhinitis. An active metabolite of terfenadine, fexofenadine is being heavily advertised as "nonsedating...without 'black box' warnings."

Trandolapril (tran doe la pril; Mavik - Knoll) has become the ninth angiotensin-converting- enzyme (ACE) inhibitor to be approved by the US Food and Drug Administration (FDA) for treatment of hypertension.

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.

High doses of estrogens, with or without a progestin, have been used for many years to prevent pregnancy after unprotected coitus (Medical Letter, 31:93, 1989). Now the FDA has approved marketing of the Preven Emergency Contraceptive Kit (Gynetics, Inc.) for this indication. The kit, which will require a prescription, includes four tablets, each containing 50 g of ethinyl estradiol and 0.25 mg of levonorgestrel, and a pregnancy test to rule out a pre-existing pregnancy, which would be a contraindication to taking the hormones.

Ciclopirox nail lacquer (Penlac - Dermik) has been approved by the FDA for treatment of mild-to-moderate onychomycosis due to Trichophyton rubrum, without involvement of the lunula. The drug has been available for many years as a lotion and cream (Loprox) for treatment of cutaneous fungal infection

Gabapentin enacarbil (Horizant – GlaxoSmithKline), a new extended-release (ER) tablet formulation of gabapentin, has been approved by the FDA for treatment of moderate-to-severe restless legs syndrome (RLS). The immediate-release (IR) formulation of gabapentin (Neurontin,and others), which is approved for treatment of epilepsy and postherpetic neuralgia, has been used for many years to treat RLS. Another ER tablet formulation of gabapentin (Gralise) has been approved by the FDA for treatment of postherpetic neuralgia.

The FDA has approved fidaxomicin (Dificid – Optimer), a new oral macrolide antibiotic, for treatment of Clostridium difficile-associated diarrhea in patients ≥18 years old. The incidence and severity of C. difficile infection (CDI) have increased in recent years with the emergence of an epidemic hypervirulent strain (NAP1/B1/027), possibly related to widespread use of fluoroquinolones.

The FDA has approved aflibercept (a flib’ er sept; Eylea – Regeneron) for treatment of neovascular (wet) age-related macular degeneration (AMD).

Icosapent ethyl (Vascepa [vas EE puh] – Amarin), the ethyl ester of eicosapentaenoic acid (EPA), has been approved by the FDA as an adjunct to diet for treatment of severe hypertriglyceridemia (≥500 mg/dL). Vascepa is the second omega-3 polyunsaturated fatty acid (PUFA) product to become available by prescription for this indication; Lovaza (formerly Omacor), which is a combination of the ethyl esters of EPA and docosahexaenoic acid (DHA), was the first. Many omega-3 PUFA-containing fish oil capsules are sold over the counter as dietary supplements.

The FDA has approved the somatostatin analog pasireotide diaspartate (Signifor – Novartis) for treatment of adults with Cushing's disease (cortisol excess caused by an ACTH-secreting pituitary tumor) who are not candidates for pituitary surgery or for whom surgery has not been curative. Pasireotide is the first drug approved in the US specifically to treat Cushing's disease. The antiprogestin mifepristone (Korlym) was approved last year for control of hyperglycemia in patients with Cushing's syndrome, which includes other causes of hypercortisolism, such as exogenous steroids and...