Femlyv (Millicent), an orally disintegrating tablet containing ethinyl estradiol and norethindrone acetate, has been approved by the FDA for prevention of pregnancy in females with a body mass index (BMI) ≤35 kg/m². It is the first hormonal contraceptive to become available in an orally disintegrating tablet formulation. Traditional oral and chewable tablets containing ethinyl estradiol and norethindrone acetate in a wide range of doses, including those found in Femlyv, have been available in the US for years.

Cefpodoxime proxetil (Vantin - Upjohn), a new third-generation oral cephalosporin, has been approved for marketing by the US Food and Drug Administration. It is available for twice-daily treatment of pharyngitis, upper and lower respiratory infections, otitis media, urinary tract infections, skin and soft tissue infections, and for single-dose treatment of uncomplicated gonorrhea in men or women and anorectal gonorrhea in women.

Terbinafine (Lamisil - Sandoz), an allylamine synthetic antifungal, previously available in the USA in a topical formulation (Medical Letter, 35:76, 1993) has now been marketed for oral use in the treatment of fungal nail infections caused by dermatophytes. Oral terbinafine has been available in Europe since 1992.

The FDA has approved a conjugate heptavalent pneumococcal vaccine for prevention of invasive pneumococcal disease in infants and children.

Apomorphine (Apokyn - Mylan/Bertek), an injected non-ergot dopamine agonist, was recently approved by the FDA for intermittent subcutaneous (SC) treatment of hypomobility ("off" episodes) in patients with advanced Parkinson's disease. It has been available in Europe for many years.

Hyperphosphatemia in end-stage renal disease can lead to secondary hyperparathyroidism, renal osteodystrophy, metastatic calcification and cardiovascular mortality. addition to dietary restriction of phosphorus and hemodialysis, drugs that bind phosphates in the gut are usually needed as well. Aluminum hydroxide is no longer recommended for long-term use because of concerns about its toxicity.

Levalbuterol, the R-isomer of the beta-2 adrenergic agonist albuterol, is now available in the US as a metered-dose inhaler (Xopenex HFA - Sepracor) for treatment of asthma in patients ≥ 4 years old. Levalbuterol has been available since 1999 in a nebulizer solution for treatment of bronchospasm in patients ≥ 6 years old.1 Outside the US, albuterol is called salbutamol, and levalbuterol is levosalbutamol.

Rituximab (Rituxan - Genentech), an anti-CD20 monoclonal antibody already marketed for treatment of B-cell non-Hodgkin's lymphoma, is now FDA-approved for use concurrently with methotrexate to treat moderate to severe rheumatoid arthritis in patients who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitors. Rituximab selectively depletes CD20+ B cells, which apparently play a role in the autoimmune response and in the chronic synovitis associated with rheumatoid arthritis.

The FDA has approved the marketing of extended release (ER) ranolazine (Ranexa - CV Therapeutics) for treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs. It should be used in combination with a nitrate, a beta-blocker or the dihydropyridine calcium-channel blocker amlodipine (Norvasc), and appears to be more effective in men. The labeling for ranolazine specifies amlodipine as the calcium-channel blocker of choice because the use of other dihydropyridines with ranolazine has not been studied, and use with diltiazem (Cardizem, and...

The FDA has approved Exforge (Novartis) and Azor (Daiichi Sankyo), the first combinations of a calcium channel blocker (CCB) with an angiotensin receptor blocker (ARB) for treatment of hypertension. Amlodipine is the CCB in both products. The ARBs are valsartan in Exforge and olmesartan in Azor. All 3 of these drugs are available in fixed-dose combinations with other antihypertensive drugs.