Fosfomycin, a broad-spectrum antibiotic used parenterally in Europe for many years, has been approved by the US Food and Drug Administration (FDA) as fosfomycin tromethamine (Monurol - Forest) for single-dose oral treatment of uncomplicated urinary tract infections in women.

Sapropterin (Kuvan - BioMarin) has been approved by the FDA to reduce phenylalanine plasma concentrations in patients with phenylketonuria (PKU). PKU is a rare genetic disorder (it occurs in 1 in 8000 Caucasian and 1 in 50,000 African-American newborns) caused by a deficiency of phenylalanine hydroxylase (PAH) the resulting high levels of the amino acid in blood and urine lead to cognitive, behavioral and other neurological complications.

The FDA has approved a new 2.5-mg formulation of the direct factor Xa inhibitor rivaroxaban (Xarelto – Janssen) for use in combination with low-dose aspirin to reduce the risk of major cardiovascular events in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD). Rivaroxaban is the first direct oral anticoagulant to be approved for this indication. It was approved earlier for prevention and treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and for prevention of stroke and systemic embolism in patients with nonvalvular atrial...

Mifepristone (RU 486; Mifeprex - Danco), an antiprogestin, has been approved by the FDA for termination of intrauterine pregnancies of 49 days or less. It is generally used with misoprostol (Cytotec - Searle), an E₁ prostaglandin analog marketed in the USA only for prevention of gastric ulcers.

The FDA has approved the intravenously administered synthetic vasopressin analog terlipressin (Terlivaz – Mallinckrodt) to improve kidney function in adults with hepatorenal syndrome (HRS) and a rapid decline in kidney function. Terlipressin is the first drug to be approved for this indication in the US; it has been available in Europe and elsewhere for year

Initial treatment of allergic rhinitis (AR) depends on the severity of symptoms and whether they are intermittent or persistent (see Table 1).

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.

Flurbiprofen (Ansaid - Upjohn), a nonsteroidal anti-inflammatory drug (NSAID) available in some countries since 1977, was recently approved by the US Food and Drug Administration for treatment of rheumatoid arthritis and osteoarthritis. Flurbiprofen is a fluorinated phenylalkanoic acid derivative structurally related to ibuprofen (Motrin;and others).

Doconsanol 10% cream, a long-chain saturated alcohol, has been approved by the FDA for over-the-counter treatment of herpes labialis.

Efbemalenograstim alfa-vuxw (Ryzneuta – Evive), a nonpegylated granulocyte colony-stimulating factor (G-CSF) conjugated to an Fc fragment of human IgG2, has been approved by the FDA to decrease the incidence of infection, as manifested by febrile neutropenia, in adults with nonmyeloid malignancies receiving myelosuppressive chemotherapy that can cause clinically significant febrile neutropenia. It is the first nonpegylated, long-acting G-CSF to become available in the US. Two pegylated, long-acting G-CSFs, pegfilgrastim (Neulasta, and biosimilars) and eflapegrastim (Rolvedon), are...