Aggrenox, a fixed-dose oral combination of aspirin and extended-release dipyridamole, is now being advertised for secondary prevention of a transient ischemic attack (TIA) or ischemic stroke.

An intraveneous (IV) formulation of ibuprofen (Caldolor - Cumberland) was recently approved by the FDA for use in adults. It can be administered alone for treatment of mild to moderate pain or as an adjunct to opioid analgesics for moderate to severe pain. It is also approved for reduction of fever.

In the past 2 years, the FDA has approved 3 new drugs for prevention or treatment of hereditary angioedema (HAE) in non-pregnant adolescents and adults: the C1 esterase inhibitor Cinryze for prophylaxis and the C1 esterase inhibitor Berinert and the kallikrein inhibitor ecallantide (Kalbitor) for treatment of acute attacks.

The FDA has approved a new injectable formulation of methotrexate (Otrexup – Antares) for use in rheumatoid arthritis and polyarticular juvenile idiopathic arthritis, and for severe psoriasis in adults. On its web site (www.otrexup.com), the manufacturer states: "Otrexup is the first subcutaneous (SC) methotrexate (MTX) for self-administration delivered once weekly by auto-injector." Methotrexate has been available as a once-weekly injection (IM or SC) for these indications for many years,1 but not specifically for self-administration and not in a single-dose auto-injector. Methotrexate is...

Cetuximab (Erbitux - ImClone Systems/Bristol-Myers Squibb), an epidermal growth factor receptor (EGFR) inhibitor, and bevacizumab (Avastin - Genentech), the first vascular endothelial growth factor angiogenesis inhibitor, have recently been approved by the FDA for treatment of patients with metastatic colorectal cancer. Cetuximab is approved for treatment of patients with EGFR-expressing tumors, either in combination regimens with irinotecan (Camptosar)when the cancer has progressed on irinotecan-based therapy, or as monotherapy for those who cannot tolerate irinotecan. Bevacizumab is approved...

Sunitinib (Sutent - Pfizer) and sorafenib (Nexavar - Bayer), two oral tyrosine kinase inhibitors, have been approved by the FDA for treatment of advanced renal cell carcinoma (RCC). Sunitinib is also approved for use in patients with gastrointestinal stromal tumor (GIST) who are not responding to or are intolerant of standard therapy with imatinib (Gleevec).

Disodium pamidronate (Aredia - Ciba-Geigy), an aminohydroxypropilidene bisphosphonate, has been approved by the US Food and Drug Administration for intravenous (IV) treatment of hypercalcemia associated with malignancy, with or without bone metastases. The drug is also being investigated for use in Paget's disease of bone, hyperparathyroidism, and postmenopausal osteoporosis. An oral formulation of pamidronate has been used in Europe, but is not available in the USA.

Rimantadine hydrochloride (Flumadine - Forest), the alpha-methyl derivative of amantadine (Symmetrel, and others), was recently approved by the US Food and Drug Administration for prevention and treatment of influenza A virus infections in adults and for prevention of influenza in children.

Glimepiride (Amaryl - Hoechst Marion Roussel), a new sulfonylurea similar to glyburide and glipizide (Medical Letter, 26:79, 1984), was recently marketed for treatment of patients with non-insulin-dependent diabetes mellitus (NIDDM) not controlled by diet and exercise. The new drug is the first sulfonylurea approved by the US Food and Drug Administration (FDA) for use concurrently with insulin.

The FDA has approved ferric citrate (Auryxia – Keryx), an oral phosphate binder, for treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. It is the second iron-based phosphate binder to be approved in the US, and the first that causes significant systemic absorption of iron. Auryxia is not FDA-approved for treatment of iron deficiency anemia.