Tacrolimus ointment (Protopic) has been approved by the FDA in 0.03% and 0.1% formulations for treatment of atopic dermatitis. Tacrolimus is used systemically (Prograf) to prevent rejection of organ transplants.

Caspofungin acetate(Cancidas) is the first of a new class of antifungals, the echinocandins. It has been approved by the FDA for treatment of invasive aspergillosis in patients who fail to respond to or are unable to tolerate other antifungal drugs such as amphotericin B and itraconazole.

Most patients with lung cancer present with advanced disease, and fewer than 20% live for five years after diagnosis. Earlier detection of lung cancer, when it is potentially resectable, might improve survival. Recent studies have led some radiology centers to promote spiral computed tomography (CT), which involves much less exposure to radiation than standard CT, as a screening tool for lung cancer.

Botulinum toxin type A (Botox - Allergan) and type B (Myobloc - Elan) are now approved by the FDA for treatment of cervical dystonia. Botulinum toxin type A has been approved since 1989 for treatment of strabismus and blepharospasm. It is also used cosmetically to reduce wrinkles on the face and neck.

Memantine hydrochloride, which has been used to treat dementia in Germany (Axura Merz) since 1982, has become the latest word-of-mouth miracle drug for Alzheimer's disease in the US (G Kolata, NY Times, June 15, 2003). Forest Laboratories has submitted a New Drug Application to the FDA for memantine. This review describes the standard treatment for Alzheimer's Disease, mechanism of action, clinical studies, adverse effects and dosage. Also included are sections on availability of the drug and how some people are obtaining memantine from abroad.

An FDA Advisory Committee has recommended over-the-counter (OTC) marketing of Plan B (Barr), an emergency contraceptive "pill pack" that contains two 0.75-mg tablets of levonorgestrel to be taken 12 hours apart (Medical Letter 2000; 42:10). Plan B is one of two FDA-approved products for this indication. The Preven Emergency Contraceptive Kit (Medical Letter, 40:102, 1998) includes four tablets, each containing 0.25 mg of levonorgestrel and 50 ╡g of ethinyl estradiol; these are taken 2 at a time 12 hours apart (the "Yuzpe regimen") and are available only by...

The combination of pemetrexed (Alimta - Lilly) and cisplatin is the first chemotherapy regimen approved by the FDA for treatment of malignant pleural mesothelioma. This uncommon malignancy, which has been linked to asbestos exposure, was previously considered unresponsive to chemotherapy, with a median survival of 6-8 months from diagnosis (VW Rusch, J Clin Oncol 2003; 21:2629).

Recombinant activated coagulation factor Vll (rFVIIa; NovoSeven - Novo Nordisk), which is marketed worldwide for treatment of bleeding episodes in hemophilia patients with inhibitors to factor VIII or IX, is now being used off-label to stop bleeding in patients who do not have hemophilia. An article in the lay press reported that one or two doses has stopped previously uncontrollable bleeding due to gunshot wounds (B Wysocki, Jr, Wall St Journal, March 17, 2004, page B1).

Palifermin (Kepivance - Amgen), a recombinant human keratinocyte growth factor (KGF), has been approved by the FDA to decrease the incidence and duration of severe oral mucositis (OM) in patients with hematologic malignancies receiving myelotoxic chemotherapy and hematopoietic stem cell (HSC) rescue.

The FDA recently announced that it was investigating 38 reports of loss of vision in men who took sildenafil (Viagra), which has been used to treat erectile dysfunction since 1998.