The FDA has approved anthrax vaccine adsorbed (AVA; BioThrax – Emergent BioSolutions) for prevention of anthrax disease in adults following exposure to Bacillus anthracis and intravenous anthrax immune globulin (Anthrasil – Emergent BioSolutions) for treatment of inhalation anthrax in adults and children. AVA has been available since 1970 for prevention of anthrax disease in persons at high risk of exposure.

Intravenous immunoglobulin (IVIG) has 6 FDA approved indications and is prescribed off-label for many others. How many of these uses are justified is controversial.

Taclonex ointment (Warner Chilcott/LEO Pharma), a combination of the vitamin D3 analog calcipotriene 0.005% (Dovonex) and the high-potency corticosteroid betamethasone dipropionate 0.064%, was recently approved by the FDA for treatment of psoriasis vulgaris in patients ≥ 18 years old.

The US manufacturer of varicella zoster immune globulin (VZIG; Massachusetts Public Health Biologic Laboratories, Boston, MA) recently discontinued its production. A Canadian formulation, VariZIG (Varicella Zoster Immune Globulin [Human] - Cangene Corporation, Winnipeg) is now available in the US under an investigational new drug application expanded access protocol.

Implanon (Organon), an implantable contraceptive containing the progestin etonogestrel, has been approved by the FDA. Two other implantable contraceptives, Norplant and Jadelle, which both contain levonorgestrel, are FDA-approved but not marketed in the US.

Decitabine (Dacogen - MGI Pharma), a pyrimidine nucleoside analog of cytidine, was approved by the FDA as an orphan drug for treatment of myelodysplastic syndromes (MDS), a heterogeneous group of clonal hemopathies that decrease production of normal blood elements (red cells, white cells and platelets) and are associated with a risk of progression to acute leukemia.

The FDA has approved an extended-release formulation of minocycline (Solodyn - Medicis) for once-daily treatment of non-nodular moderate to severe acne.

Celiac disease is a chronic autoimmune disorder caused by a genetic intolerance to gluten that occurs in about 1% of the population. The main form of treatment is a lifelong gluten-free diet.

The FDA has approved the marketing of a second fixed-dose combination of extended-release niacin (Niaspan) with a generic statin. Niaspan/simvastatin (Simcor - Abbott) is approved for use in patients with hypercholesterolemia or mixed dyslipidemia (high LDL-cholesterol, low HDL-cholesterol and high serum triglycerides). Niaspan/lovastatin (Advicor) was marketed previously for the same indications.

The FDA has approved an oral, fixed-dose combination (Treximet - GlaxoSmithKline) of the selective serotonin receptor agonist ("triptan") sumatriptan (Imitrex) and the nonsteroidal anti-inflammatory drug (NSAID) naproxen sodium (Anaprox, and others) for acute treatment of migraine attacks.