The FDA has approved Symbravo (Axsome), an oral fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) meloxicam and the 5-HT_1B/1D receptor agonist (triptan) rizatriptan (Maxalt, and generics), for acute treatment of migraine with or without aura in adults. It is the second combination of an NSAID and a triptan to be approved for migraine treatment. An oral fixed-dose combination of sumatriptan and naproxen (Treximet, and generics) is approved for use in patients ≥12 years old.

Captopril (Capoten - Bristol-Myers Squibb), an angiotensin-converting enzyme (ACE) inhibitor previously available for treatment of hypertension, has now been approved by the US Food and Drug Administration (FDA) for treatment of diabetic nephropathy in patients with insulin-dependent diabetes mellitus (IDDM). Diabetic nephropathy is the most common cause of end-stage renal disease in the United States.

Dexfenfluramine (Redux - Wyeth-Ayerst) has been approved by the US Food and Drug Administration as an aid to diet for treatment of obesity and maintenance of weight loss. Dexfenfluramine is the dextrorotatory isomer of d,l-fenfluramine (Pondimin), which has been marketed for short-term weight reduction for many years and recently has been widely used in combination with phentermine (Ionamin, and others), a sympathomimetic drug (Medical Letter, 36:107, 1994).

The FDA has approved bremelanotide (Vyleesi – Amag), a melanocortin receptor agonist, for subcutaneous treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). Bremelanotide is not approved for use in men or postmenopausal women. It is the second drug to be approved in the US for this indication; flibanserin (Addyi), which was approved in 2015, was the first.

The FDA has approved a combination oral contraceptive containing the estrogen estetrol and the progestin drospirenone (Nextstellis – Mithra/Mayne). Estetrol is the first new estrogen to become available in the US in 50 years. Drospirenone is available alone (Slynd) and in combinations with the estrogen ethinyl estradiol for prevention of pregnancy.

View the Comparison Table: Some FDA-Approved Drugs for Weight Management

Tacrolimus (Prograf - Fujisawa), previously called FK506 (Medical Letter, 33:94, 1991), has been approved by the US Food and Drug Administration for primary prevention of organ rejection in patients receiving liver transplants. The drug has also been used as rescue therapy for organ graft rejection unresponsive to cyclosporine (Sandimmune) and other immunosuppressive drugs.

Opioids, benzodiazepines, propofol, antipsychotics and dexmedetomidine (Precedex) are frequently used in the intensive care unit (ICU) to manage pain, anxiety, agitation and delirium, and to facilitate procedures such as mechanical ventilation. The use of dexmedetomidine, a centrally-acting selective α₂-receptor agonist approved by the FDA in 1999, has been increasing in recent years. Some new studies comparing it to other drugs for ICU sedation have been published.

The FDA has approved belatacept (bel at´ a sept; Nulojix – Bristol-Myers Squibb) for prevention of organ rejection in adult patients receiving a kidney transplant.

Axitinib (Inlyta – Pfizer), an oral tyrosine kinase inhibitor, has been approved by the FDA for treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. It is the fourth oral tyrosine kinase inhibitor to be approved for treatment of advanced renal cell carcinoma.