The FDA has approved the use of aliskiren (Tekturna), a direct renin inhibitor, with valsartan (Diovan), an angiotensin-receptor blocker (ARB), in a fixed-dose combination as Valturna (Novartis) for treatment of hypertension in patients already taking both drugs or not adequately controlled on monotherapy, and as initial therapy in those likely to need multiple drugs to control their blood pressure.

The FDA has approved Duzallo (Ironwood), a fixed-dose combination of the uric acid transporter 1 (URAT1) inhibitor lesinurad (Zurampic) and the xanthine oxidase inhibitor allopurinol (Zyloprim, and generics), for once-daily treatment of gout-associated hyperuricemia in patients who have not achieved target serum uric acid levels with allopurinol alone.

The FDA has approved peanut allergen powder-dnfp (Palforzia – Aimmune) for use as oral immunotherapy to mitigate allergic reactions, including anaphylaxis, caused by accidental peanut exposure in patients with a confirmed peanut allergy. It is the first drug to be approved in the US for this indication; Viaskin Peanut, an immunotherapy patch, is under FDA review for the same indication.

Teplizumab-mzwv (Tzield – Provention Bio), an anti-CD3 monoclonal antibody, has been approved by the FDA to delay the onset of stage 3 type 1 diabetes in patients ≥8 years old who have stage 2 type 1 diabetes. It is the first drug to become available in the US that delays the onset of type 1 diabetes.

The FDA has approved Cobenfy (BMS), an oral fixed-dose combination of the muscarinic agonist xanomeline and the peripheral muscarinic antagonist trospium chloride, for treatment of schizophrenia in adults. It is the first antipsychotic drug to be approved in the US for treatment of schizophrenia that does not block dopamine receptors. This is the first approval for xanomeline; trospium has been available for many years for treatment of overactive bladder.

Naftifine hydrochloride 1% cream (Naftin - Herbert Laboratories), was recently approved by the US Food and Drug Administration (FDA) for topical treatment of tinea cruris and tinea corporis. It is available only by prescription.

Self-injection of papaverine, a smooth muscle relaxant, and phentolamine (Regitine), an alpha-adrenergic blocker, directly into the corpus cavernosum has been effective for treatment of impotence in some patients, even after complete quadriplegia, radical surgery for bladder or prostate cancer, or castration (Medical Letter, 29:95, 1987). Recently, injections of prostaglandin E1, now called alprostadil (Prostin VR - Upjohn), have also been tried for this purpose. No drug is approved for this use by the US Food and Drug Administration.

Fluvastatin (Lescol - Sandoz), an HMG-CoA reductase inhibitor, was recently marketed in the USA for treatment of hypercholesterolemia. A synthetic mevalonolactone derivative, it is chemically distinct from previously available drugs in this class.

Grepafloxacin (Raxar - Glaxo Wellcome), a once-daily oral fluoroquinolone, is now being marketed for treatment of community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, uncomplicated gonorrhea, and nongonococcal urethritis and cervicitis.

Ciclopirox nail lacquer (Penlac - Dermik) has been approved by the FDA for treatment of mild-to-moderate onychomycosis due to Trichophyton rubrum, without involvement of the lunula. The drug has been available for many years as a lotion and cream (Loprox) for treatment of cutaneous fungal infection