Rosiglitazone, the second thiazolidinedione derivative to be marketed in the USA for treatment of type 2 diabetes, has been approved by the FDA for use either alone or combined with meformin.

Desloratadine (des lor at' a deen; Clarinex - Schering), an active metabolite of the H1-receptor antagonist loratadine (Claritin), has been approved by the FDA for oral treatment of allergic rhinitis and chronic urticaria in patients at least 12 years old. The patent for loratadine expires in December 2002, and generic or over-the-counter versions are expected.

Pramlintide acetate (Symlin - Amylin Pharmaceuticals), a synthetic analog of human amylin, has been approved by the FDA as adjunctive treatment for patients with type 1 or type 2 diabetes who inject insulin at mealtimes and have failed to achieve glucose control. Pramlintide is injected subcutaneously before meals.

Duloxetine hydrochloride (Cymbalta - Lilly), a selective serotonin and norepinephrine reuptake inhibitor (SNRI) available for treatment of depression, has also been approved by the FDA for treatment of neuropathic pain associated with diabetic peripheral neuropathy (DPN). Duloxetine is one of two drugs approved specifically for management of neuropathic pain due to diabetes; the other, pregabalin (Lyrica - Pfizer), will be marketed soon and will be reviewed in the next issue of The Medical Letter.

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.

Canagliflozin (kan" a gli floe' zin; Invokana – Janssen), a sodium-glucose co-transporter 2 (SGLT2) inhibitor, has been approved by the FDA for oral treatment of type 2 diabetes.

Tacrolimus ointment (Protopic) has been approved by the FDA in 0.03% and 0.1% formulations for treatment of atopic dermatitis. Tacrolimus is used systemically (Prograf) to prevent rejection of organ transplants.

The combination of pemetrexed (Alimta - Lilly) and cisplatin is the first chemotherapy regimen approved by the FDA for treatment of malignant pleural mesothelioma. This uncommon malignancy, which has been linked to asbestos exposure, was previously considered unresponsive to chemotherapy, with a median survival of 6-8 months from diagnosis (VW Rusch, J Clin Oncol 2003; 21:2629).

The FDA has approved a sumatriptan iontophoretic transdermal system (Zecuity – Teva) for acute treatment of migraine in adults. Sumatriptan, the first of seven serotonin receptor antagonists (triptans) approved for this indication, is the most frequently prescribed migraine treatment in the US. It is also available in oral, intranasal, and injectable formulations.