Two new fluoroquinolone solutions, moxifloxacin 0.5% (Vigamox - Alcon) and gatifloxacin 0.3% (Zymar - Allergan) are now available in the US for ophthalmic use in treatment of bacterial conjunctivitis.

Vytorin, a fixed-dose combination of the cholesterol absorption inhibitor ezetimibe (Zetia - Merck/Schering Plough) and the HMG-CoA reductase inhibitor ("statin") simvastatin (Zocor - Merck), has been approved by the FDA for treatment of hypercholesterolemia. It is available as tablets containing 10 mg of ezetimibe combined with 10, 20, 40 or 80 mg of simvastatin.

The FDA has approved marketing of the corticosteroid mometasone furoate in an orally inhaled dry powder formulation (Asmanex Twisthaler - Schering-Plough) for maintenance treatment of asthma in patients at least 12 years old. Mometasone is also available as a mid-potency topical corticosteroid cream (Elocon) and as an intranasal spray (Nasonex) for treatment of allergic rhinitis.

A fixed-dose combination of oxycodone 5 mg and ibuprofen 400 mg (Combunox - Forest Laboratories) is now available and is being heavily advertised for short-term treatment of moderate to severe acute pain.

Gamma hydroxybutyrate (GHB), a central-nervous-system depressant notorious for its use in "date rape", was approved by the FDA in 2002 as sodium oxybate (Xyrem - Jazz Pharmaceuticals) for oral treatment of cataplexy in patients with narcolepsy. Now it has also been approved for treatment of excessive daytime sleepiness (EDS) in these patients. Xyrem is a Schedule III controlled substance.

Atripla (Gilead/Bristol-Myers Squibb) is the first once daily, single-tablet combination of 3 antiretroviral drugs for treatment of HIV infection. Each tablet contains 600 mg of the non-nucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (Sustiva), 200 mg of the nucleoside reverse transcriptase inhibitor (NRTI) emtricitabine (Emtriva), and 300 mg of the nucleotide reverse transcriptase inhibitor (NRTI) tenofovir DF (Viread). These drugs have been recommended for use together, if resistance testing confirms susceptibility, as an initial regimen of choice for treatment-na∩ve...

A new once-daily, low-dose oral formulation of doxycycline monohydrate (Oracea - CollaGenex) has been approved by the FDA for treatment of inflammatory papules and pustules associated with rosacea in adults.

A combination tablet containing estradiol and drospirenone (Angeliq - Berlex) recently became available for treatment of moderate to severe menopausal symptoms in women with an intact uterus. Since the last Medical Letter issue reviewing such devices,1 more continuous glucose monitoring (CGM) systems have become available. Five devices available now, and two expected to be marketed soon, are listed in the table on page 14. The FDA has approved continuous glucose devices only for the observation of glucose trends.

The FDA has approved an agonist/antagonist combination of morphine and naltrexone (Embeda – King) for treatment of chronic moderate to severe pain requiring around-the-clock analgesia for an extended period of time. The addition of naltrexone is intended to prevent abuse of morphine.

The FDA has approved a nasal spray fixed-dose combination (Dymista – Meda) of the H₁-antihistamine azelastine (Astelin, Astepro, and generics) and the corticosteroid fluticasone propionate (Flonase, and generics) for treatment of seasonal allergic rhinitis (SAR) in patients ≥12 years old who need both medications for symptomatic relief. It is the first nasal spray to be approved in the US that contains both an H₁-antihistamine and a corticosteroid.