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.

Duloxetine (Cymbalta - Lilly) is the second drug to be approved by the FDA for treatment of fibromyalgia. Pregabalin (Lyrica), which is also approved for treatment of neuropathic pain and epilepsy, was the first. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) that is already marketed for treatment of depression and diabetic neuropathy.

The bisphosphonate risedronate (Actonel - Procter & Gamble) was recently approved by the FDA in a 150- mg once-monthly oral tablet for prevention and treatment of postmenopausal osteoporosis. The drug is also available for the same indication in 5-mg daily, 35-mg weekly and 75-mg twice-monthly tablets.

The FDA has approved the use of the 5α-reductase inhibitor dutasteride (Avodart - GlaxoSmithKline) together with the alpha₁-blocker tamsulosin (Flomax - Boehringer Ingelheim) for treatment of benign prostatic hyperplasia (BPH). Use of an alpha1-blocker with a 5α-reductase inhibitor has been a common practice for years, but FDA approval of a particular combination permits the manufacturers to add an indication for it in both package inserts, recommend dosage for combination use, and advertise the benefits of using the 2 drugs together.

The treatment of choice to prevent emesis due to highand moderate-risk emetogenic drugs used in cancer chemotherapy is aprepitant plus a serotonin receptor antagonist plus dexamethasone. Four serotonin receptor antagonists are available in the US in intravenous (IV) formulations for prevention of nausea and vomiting due to cancer chemotherapy, and 3 of these are also available for oral use. Now the FDA has approved one of these, granisetron, in a transdermal formulation (Sancuso - ProStrakan).

Continued use of a long-acting beta-2 agonist for treatment of asthma may cause down-regulation of the beta-2 receptor with loss of the bronchoprotective effect from rescue therapy with a short-acting beta-2 agonist. After a large study (SMART) found an increased risk of asthma-related deaths in patients receiving the long-acting beta-2 agonist salmeterol, a boxed warning was added to the labeling of all medications containing a long-acting beta-2 agonist. Now the FDA has completed a meta-analysis of 110 asthma treatment studies in 60,954 patients taking any of the long-acting beta-2 agonist...

The incidence of oral cancer appears to be increasing, especially in younger patients. Risk factors include use of tobacco and alcohol, and exposure to human papillomavirus. ViziLite Plus (Zila Pharmaceuticals) is a combination device that uses fluorescent light and toluidine blue tissue staining to help dentists identify abnormal changes in the mucous membranes of the oral cavity. Originally developed for detecting abnormal growths on the uterine cervix, in 2001 it received FDA clearance for "identification, evaluation, and monitoring of oral mucosal abnormalities in a patient population at...

The FDA has approved a delayed-release capsule formulation of valproic acid (VPA; Stavzor - Noven Therapeutics) for all of the indications for which divalproex sodium (Depakote, and others; Depakote ER) is approved: monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures, and adjunctive therapy in patients with multiple seizure types that include absence seizures; acute treatment of manic episodes associated with bipolar disorder; and prophylaxis of migraine headaches. In addition, valproate (valproic acid or divalproex sodium) is considered a...

Apriso (Salix) is a new formulation of mesalamine (5-aminosalicylic acid; 5-ASA) approved by the FDA for maintenance of remission in mild to moderate ulcerative colitis (UC). Mesalamine is a locally acting antiinflammatory agent that is widely used both to maintain and induce remission in inflammatory bowel disease. Various mesalamine formulations have been developed to target drug delivery to areas of the small intestine and colon. Most of these agents require frequent dosing and have a high pill burden. The newest products - Lialda, introduced in 2007,1 and now Apriso - can be dosed once...

A 23-valent polysaccharide vaccine (PPSV23; Pneumovax 23 - Merck) is the only pneumococcal vaccine approved for use in adults. It has reduced the risk of invasive pneumococcal disease (meningitis or bacteremic pneumonia), but not mortality, in immunocompetent older adults.2 PPSV23 has not been shown to reduce the risk of invasive pneumococcal disease (IPD) in immunocompromised patients.

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