The FDA has approved tapentadol hydrochloride (Nucynta - Ortho-McNeil Janssen) for oral treatment of moderate to severe acute pain in patients ≥18 years old. It has been classified as a Schedule II controlled substance

The FDA has licensed 4 new monovalent vaccines for prevention of respiratory illness caused by a new influenza A H1N1 virus that appears to be derived from a swine strain. The 5th vaccine should be licensed soon. All of these vaccines are expected to become available in October. An intranasal formulation is expected in the first week of October.

Dronedarone (Multaq - Sanofi-Aventis) has been approved by the FDA for oral treatment of atrial fibrillation and flutter. Amiodarone (Cordarone, and others) is the most effective drug for this indication, but has considerable toxicity.

The FDA has approved the marketing of iloperidone (Fanapt – Vanda), a second-generation antipsychotic, for treatment of schizophrenia. Iloperidone is chemically related to risperidone (Risperdal, and others).

The FDA has approved degarelix (Firmagon - Ferring), a synthetic decapeptide gonadotropin-releasing hormone (GnRH) receptor antagonist, for rapid medical castration of men with advanced prostate cancer. Abarelix (Plenaxis), the first GnRH antagonist approved by the FDA, was withdrawn from the US market because of immediate hypersensitivity reactions.

Until the recent introduction of febuxostat (Uloric), no new drugs had been marketed for treatment of gout in the past 40 years. Colchicine, which has been available for decades as an unapproved drug, has now been approved by the FDA (Colcrys) for treatment and prophylaxis of gout flares. It was approved earlier only in combination with probenecid (Colbenemid, and others). The goals of gout treatment are three-fold: treating acute disease, preventing flares and reducing uric acid stores.

The FDA has approved the fluoroquinolone besifloxacin 0.6% ophthalmic suspension (Besivance - Bausch & Lomb) for treatment of bacterial conjunctivitis caused by susceptible bacteria. According to the manufacturer, this product was developed specifically for ophthalmic use in a specialized vehicle designed to prolong contact time on the ocular surface. Besifloxacin is not available for systemic use.

Recent news articles about mercury in fish may lead some patients to seek more information from their healthcare providers. For most Americans, seafood is the major source of exposure to mercury. The mercury in seafood is in the form of methylmercury, a potential neurotoxin formed by the organification of elemental mercury by marine microorganisms like plankton, which are then consumed by aquatic animals and concentrated up the food chain.

Everolimus (Afinitor – Novartis) and pazopanib (Votrient – GlaxoSmithKline), two oral multikinase inhibitors, have been approved by the FDA for treatment of advanced renal cell carcinoma. Sunitinib (Sutent) and sorafenib (Nexavar), two other oral multikinase inhibitors, and temsirolimus (Torisel), an IV multikinase inhibitor, were approved earlier for the same indication.

The FDA has approved tramadol hydrochloride extended-release (Ryzolt – Purdue) for treatment of moderate to moderately severe chronic pain in adults. Tramadol is already available in another extended-release formulation (Ultram ER) and in immediate-release tablets alone (Ultram, and others) and combined with acetaminophen (Ultracet, and others).