Sodium phenylbutyrate, an "orphan drug,"has recently been marketed for the treatment of patients with urea cycle disorders caused by a deficiency in one of the following hepatic enzymes: carbamyl phosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). Urea cycle disorders are rare; they occur in one of every 10,000 births.

Imiquimod (i mi kwi' mod) 5% cream (Aldara - 3M Pharmaceuticals) has been approved by the FDA for treatment of external genital and perianal warts (condyloma acuminata). The drug requires a prescription but is applied by the patient. It is the second patient-applied treatment to become available for external genital warts; the first was podofilox (Condylox - Medical Letter, 33:117, 1991).

Irbesartan (Avapro - Sanofi/Bristol-Myers Squibb) is the third angiotensin II receptor antagonist to become available in the USA for oral treatment of hypertension. Losartan (Cozaar) and valsartan (Diovan) were marketed earlier. Eprosartan (Teveten - SmithKline Beecham) has been approved by the FDA but not marketed.

Sodium hyaluronate (Hyalgan - Sanofi) and hylan G-F 20 (Synvisc - Wyeth- Ayerst) have been approved by the FDA for intra-articular injections in patients with knee pain due to osteoarthritis. Hylan G-F 20 is a cross-linked derivative of hyaluronic acid with a higher molecular weight than sodium hyaluronate. 'Hyaluronan' refers to either the acid or its salt.

Tamoxifen, anti-estrogen used for many years in the treatment of breast cancer, has now been approved by the FDA for reducing the incidence of breast cancer in women at increased risk of developing the disease.

The FDA has approved use of denosumab (Prolia – Amgen) for treatment of osteoporosis in postmenopausal women at high risk for fracture.

The FDA has approved a topical 8% patch formulation of capsaicin (Qutenza – NeurogesX), available only by prescription, for local treatment of postherpetic neuralgia. Postherpetic neuralgia occurs after herpes zoster in about one third of patients ≥60 years old and can persist for months or even years.

The angiotensin receptor blocker (ARB) azilsartan medoxomil (Edarbi – Takeda) was recently approved by the FDA for oral treatment of hypertension, either alone or combined with other drugs. It is the eighth ARB approved for this indication.

The FDA has approved Nuedexta (Avanir), a fixed-dose combination of the cough suppressant dextromethorphan hydrobromide and the antiarrhythmic quinidine sulfate, for oral treatment of pseudobulbar affect. The combination is the first treatment approved by the FDA for this indication. Studies to support the effectiveness of Nuedexta were performed in patients with underlying amyotrophic lateral sclerosis (ALS) or multiple sclerosis (MS); the drug has not been shown to be safe or effective in other types of emotional lability.

Roflumilast (Daliresp – Forest), an oral phosphodiesterase 4 (PDE4) inhibitor, was approved by the FDA to reduce the risk of exacerbations in adult patients with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations.