The FDA has approved the marketing of tolvaptan (Samsca - Otsuka), an oral vasopressin receptor antagonist, for treatment of hypervolemic or euvolemic hyponatremia due to congestive heart failure (CHF), cirrhosis or the syndrome of inappropriate antidiuretic hormone secretion (SIADH). A similar drug, conivaptan (Vaprisol) is already available for intravenous (IV) treatment of euvolemic hyponatremia in hospitalized patients. Tolvaptan was approved by the FDA for both inpatient and outpatient use, but it should be started in a hospital.

The FDA has approved nasal spray formulations of the benzodiazepines diazepam (Valtoco — Neurelis) and midazolam (Nayzilam — UCB) for acute treatment of intermittent episodes of frequent seizure activity (seizure clusters). Diazepam rectal gel (Diastat, Diastat AcuDial, and generics) has been used for this indication for many years.

The FDA has approved vonoprazan (Voquezna – Phathom), a potassium-competitive acid blocker, for healing and maintenance of healing of all grades of erosive esophagitis and relief of associated heartburn in adults. Vonoprazan is also available copackaged with amoxicillin (Voquezna Dual Pak) and with amoxicillin and clarithromycin (Voquezna Triple Pak) for treatment of Helicobacter pylori infection in adults.

Atrial fibrillation (AF) is the most common arrhythmia in the world. Risk factor modification, anticoagulation, rhythm control, and rate control are the four pillars of its management. American College of Cardiology/American Heart Association (ACC/AHA) guidelines on management of AF were updated recently.

The FDA has approved the marketing of fenofibric acid (Trilipix - Abbott) to reduce triglycerides and increase HDL-C in patients with mixed dyslipidemia on optimal doses of a HMG-CoA reductase inhibitor (statin) who have, or have risk factors for, coronary heart disease. It is the first fibrate approved by the FDA specifically for combined use with a statin. Trilipix is also approved as monotherapy for hypertriglyceridemia, hypercholesterolemia and low HDL-C. The patent for Tricor, Abbott's older formulation of fenofibrate, will expire in 2011.

Dapagliflozin (dap" a gli fl oe' zin; Farxiga – Bristol-Myers Squibb/AstraZeneca), an SGLT2 (sodium-glucose co-transporter 2) inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes. Dapagliflozin is the second SGLT2 inhibitor to be approved for this indication; canagliflozin (Invokana) was the first .

Varenicline tartrate (Chantix - Pfizer) is now available for oral treatment of tobacco dependence. Some other drugs for this indication are listed in this article.

Etodolac (Lodine - Wyeth-Ayerst), a nonsteroidal anti-inflammatory drug (NSAID) available in Europe for several years, was recently approved by the U.S. Food and Drug Administration for use in osteoarthritis and as a general-purpose analgesic. It has not been approved for treatment of rheumatoid arthritis.

Tegaserod maleate (teg a ser' od; Zelnorm - Novartis), a serotonin derivative, has received FDA approval for short-term treatment of women with irritable bowel syndrome (IBS) whose primary symptom is constipation. Alosetron (Lotronex), which was withdrawn previously because of toxicity, will soon be available again for women with severe diarrhea-predominant IBS (Medical Letter 2002; 44:67).

The FDA has approved Jentadueto XR (Boehringer Ingelheim/Lilly), a once-daily extended-release formulation of the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin and the biguanide metformin, for oral treatment of type 2 diabetes. Linagliptin and metformin have been available for years in a twice-daily immediate-release combination (Jentadueto). Once-daily extended-release formulations combining metformin with the DPP-4 inhibitors saxagliptin (Kombiglyze XR) and sitagliptin (Janumet XR) are also available.