Celecoxib, a selective COX-2 inhibitor, has been approved by the FDA for treatment of osteoarthritis and rheumatoid arthritis.

Methylphenidate is now available in a new extended-release formulation (Metadate CD - Celltech) for treatment of attention deficit/hyperactivity disorder (ADHD). The new product, which is a Schedule II controlled substance, is being advertised directly to consumers.

Escitalopram (Lexapro - Forest), the active S-enantiomer of racemic citalopram (Celexa - Forest), a selective serotonin reuptake inhibitor (SSRI), was recently approved by the FDA for treatment of depression. The manufacturer plans to stop promoting Celexa in favor of Lexapro; Celexa will continue to be available for patients already taking it.

The FDA has approved the oral direct thrombin inhibitor dabigatran (da big’ a tran) etexilate (Pradaxa – Boehringer Ingelheim) for prevention of thromboembolic stroke in patients with non-valvular atrial fibrillation. It has been available in Canada (Pradax) since 2008 for prevention of thromboembolism in patients undergoing knee or hip replacement surgery and was recently approved there for use in atrial fibrillation.

Pegloticase (Krystexxa – Savient), a PEGylated urate oxidase enzyme, has been approved by the FDA for intravenous (IV) treatment of chronic symptomatic gout in adults who have not responded to maximum doses of a xanthine oxidase inhibitor, such as allopurinol (Zyloprim, and others). Pegloticase is the second new drug approved for gout in more than 40 years; a new xanthine oxidase inhibitor, febuxostat (Uloric), was approved in 2009.

The FDA has approved rilpivirine (Edurant – Janssen), a non-nucleoside reverse transcriptase inhibitor (NNRTI), for use with other antiretroviral agents for treatment of HIV-1 infection in treatment-naive adults. Rilpivirine is also available in a fixed-dose combination with emtricitabine and tenofovir (Complera – Gilead).

The FDA has approved a subcutaneously injected formulation of recombinant human parathyroid hormone (Natpara – NPS) as an adjunct to calcium and vitamin D to control hypocalcemia in adults with hypoparathyroidism. Natpara is an 84-amino acid single-chain polypeptide identical to native parathyroid hormone. It is the first parathyroid hormone formulation to be approved for this indication.

The FDA has approved droxidopa (Northera – Lundbeck) for oral treatment of adults with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, or pure autonomic failure), dopamine beta-hydroxylase deficiency, or nondiabetic autonomic neuropathy. This is the first approval for droxidopa in the US. It has been available in Japan for use in NOH since 1989.

The FDA has approved Liletta, an intrauterine device (IUD) that releases the synthetic progestin levonorgestrel, for prevention of pregnancy for up to 3 years. The fourth IUD to be approved in the US, and the third that releases levonorgestrel, Liletta is comarketed by Actavis and Medicines360, a nonprofit women's health pharmaceutical company. The wholesale cost of Liletta is similar to that of other IUDs (see Table 1), but the manufacturer offers programs that significantly reduce the cost for commercially-insured patients and clinics serving low-income women.

The FDA has approved a sumatriptan iontophoretic transdermal system (Zecuity – Teva) for acute treatment of migraine in adults. Sumatriptan, the first of seven serotonin receptor antagonists (triptans) approved for this indication, is the most frequently prescribed migraine treatment in the US. It is also available in oral, intranasal, and injectable formulations.