Natalizumab, a recombinant humanized monoclonal antibody, has received accelerated approval from the FDA for intravenous treatment of relapsing forms of multiple sclerosis (MS). The beta interferons and glatiramer acetate are widely used for treatment of MS; they generally reduce the number of relapses by about 30% compared to placebo, and have been shown to be safe and effective for periods ranging from 4 to 10 years.

Ropinirole (Requip - GlaxoSmithKline), a dopamine agonist already available for treatment of Parkinson's disease, is now the first drug approved by the FDA for treatment of moderate to severe restless legs syndrome (RLS).

For patients with diabetes poorly controlled with a single oral drug, addition of a second drug with a different mechanism can be helpful. A fixed-dose combination (Actoplus met - Takeda) of two widely used antihyperglycemic drugs, the thiazolidinedione pioglitazone (Actos) and the biguanide metformin (Glucophage, and others), has been approved by the FDA for management of type 2 diabetes. It is indicated for patients already being treated with both pioglitazone and metformin or as second-line therapy for those not adequately controlled with either metformin or pioglitazone alone....

Posaconazole (Noxafil - Schering-Plough), an oral azole antifungal with a chemical structure similar to that of itraconazole (Sporanox), has been approved by the FDA to prevent Candida and Aspergillus infections in severely immunocompromised patients and for treatment of oropharyngeal candidiasis. It is likely also to be used off-label for treatment of other fungal infections, including those caused by Mucor and other Zygomycetes.

Standard approaches to therapy for gastroesophageal reflux disease (GERD) include lifestyle changes, over-the-counter and prescription drugs, and sometimes surgery. Emerging endoscopic anti-reflux procedures that are less invasive than surgery are potential additions to current treatment options. An endoscopicallyguided radiofrequency (RF) energy delivery system, Stretta (Curon Medical), was approved by the FDA for treatment of GERD in 2000.

Sitagliptin phosphate (Januvia - Merck) is the first dipeptidyl-peptidase-4 (DPP-4) inhibitor to be marketed for treatment of type 2 diabetes. It has been approved by the FDA for oral use as monotherapy or in combination with metformin (Glucophage, and others), pioglitazone (Actos) or rosiglitazone (Avandia).

The dopamine agonist pramipexole (Mirapex - Boehringer Ingelheim) is the second drug approved by the FDA for treatment of moderate to severe restless legs syndrome (RLS). Ropinirole (Requip), another dopamine agonist, was approved for RLS in 2005. Both of these drugs were first approved for treatment of Parkinson's disease.

Sitagliptin (Januvia) and metformin (Glucophage, and others) are now available in a single tablet (Janumet - Merck) for treatment of type 2 diabetes. The combination is approved by the FDA for use in patients not adequately controlled by sitagliptin or meformin alone or in those already taking both drugs. Metformin is also available in combination with the thiazolidinediones pioglitazone and rosiglitazone and with the sulfonylureas glipizide and glyburide.

The FDA has approved the marketing of Resperate (InterCure), a device that helps patients breathe slowly, as an adjunct for treatment of hypertension. The FDA does not require proof of effectiveness for approval of devices with minimal potential for harm, such as this one.

Lapatinib (Tykerb - GlaxoSmithKline), an oral inhibitor of both HER-2 and epidermal growth factor receptor type 1 (EGFR-1 or ErbB-1), has been approved by the FDA for use in combination with capecitabine (Xeloda) to treat advanced or metastatic breast cancer that overexpresses HER-2 in patients who have received prior therapy that included an anthracycline, a taxane and trastuzumab (Herceptin), an intravenous monoclonal antibody that also inhibits HER-2.