Epoprostenol sodium (Flolan - Glaxo Wellcome), also known as prostacyclin, has been approved by the US Food and Drug Administration for continuous intravenous treatment of primary pulmonary hypertension.

Bicalutamide (Casodex - Zeneca), an oral nonsteroidal antiandrogen similar to flutamide (Eulexin - Medical Letter, 31:72, 1989), is now available in the USA for treat-ment of advanced prostate cancer. The drug is recommended by the manufacturer for use concurrently with an analog of luteinizing hormone-releasing hormone (LHRH) such as leuprolide (Lupron; Lupron Depot) or goserelin (Zoladex -Medical Letter, 32:102, 1990).

Glatiramer acetate (Copaxone - Teva Marion Partners), formerly known as copolymer-l, has been approved by the US Food and Drug Administration (FDA) for treatment of relapsing-remitting multiple sclerosis (MS). Interferon β-1b (Betaseron) and interferon β-1a (Avonex - Medical Letter, 38:63, 1996) were previously approved for this indication.

The FDA has approved glucarpidase (Voraxaze – BTG International) for treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. Glucarpidase has been available in the US since 2007 under a compassionate use open-label treatment protocol (Clinical Trials and Consulting Services, 1-877-398-9829), which will remain in effect until the drug becomes commercially available later this year. There is currently a shortage of IV methotrexate in the US.

The FDA has approved Kimyrsa (Melinta), a new IV formulation of the long-acting lipoglycopeptide antibiotic oritavancin, for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria. Orbactiv (Melinta), another IV formulation of oritavancin, was approved in 2014 for the same indication. Kimyrsa has a smaller infusion volume (250 mL vs 1 L) and a shorter infusion time (1 hour vs 3 hours) compared to Orbactiv (see Table 1).

A reader asked us to review use of the phosphodiesterase-5 (PDE5) inhibitor sildenafil for treatment of Alzheimer's disease (AD).

The FDA has authorized over-the-counter (OTC) sale of a nonmedicated alcohol-based gel (Eroxon – Futura) for treatment of erectile dysfunction (ED) in males ≥22 years old. Eroxon is the only FDA-approved OTC and topical treatment for erectile dysfunction. It is also available in the UK and the EU.

The FDA has approved daclizumab (Zinbryta – Biogen/Abbvie), an interleukin-2 (IL-2) receptor blocking monoclonal antibody, for treatment of adults with relapsing forms of multiple sclerosis (MS). It is the first subcutaneously injected monoclonal antibody to be approved for treatment of MS.

Anastrozole (Arimidex - Zeneca), a selective nonsteroidal aromatase inhibitor, has been approved by the US Food and Drug Administration (FDA) for treatment of postmenopausal women with advanced breast cancer that has progressed during treatment with tamoxifen (Nolvadex, and others).

Recombinant human α-L-iduronidase (laronidase; Aldurazyme BioMarin/Genzyme), an orphan drug, has been approved by the FDA for enzyme replacement therapy in mucopolysaccharidosis (MPS) type I, a lysosomal storage disorder caused by deficiency of the enzyme. This review describes the disease, treatment, adverse effects and cost.