Cevimeline hydrochloride, an acetylcholine derivative, has been approved by the FDA for treatment of dry mouth symptoms caused by Sjogren's syndrome. Presumably it could also be used to treat radiation-induced xerostomia in patients with head and neck cancer. Pilocarpine hydrochloride is FDA-approved for both indications

Eflornithine hydrochloride cream 13.9% (Vaniqa - Bristol-Myers Squibb) has been approved by the FDA for reduction of unwanted facial hair in women.

Anakinra (Kineret - Amgen), an interleuken-1 (IL-1) receptor antagonist, has been approved by the FDA for treatment of moderately to severly active rheumatoid arthritis in adults who have failed at least one disease-modifying anti-rheumatic drug(DMARD) such as methotrexate (Medical Letter 2000; 24:57).

Sevelamer carbonate (Renvela – Genzyme), a buffered form of the anion-exchange resin sevelamer hydrochloride (Renagel – Genzyme),1 has been approved by the FDA for use in patients with chronic kidney disease on dialysis. According to the manufacturer, Renvela will replace Renagel, which has been shown to induce or exacerbate metabolic acidosis in patients on dialysis. Two randomized, crossover studies found the two sevelamer salts equivalent in their ability to lower serum phosphate.2,3 Patients taking the carbonate had higher serum bicarbonate concentrations and fewer gastrointestinal...

The FDA has approved a new low-dose formulation of the tricyclic antidepressant doxepin (Silenor – Somaxon) for treatment of insomnia associated with sleep maintenance. The manufacturer claims that this dose retains the hypnotic effect of doxepin, without typical tricyclic adverse effects. Doxepin is available generically in higher-strength capsules and in a liquid formulation.

The FDA has approved a lingual aerosol formulation of nitroglycerin (NitroMist – Akrimax) for acute relief of an attack or acute prophylaxis of angina pectoris. It is the second nitroglycerin lingual spray to become available in the US; Nitrolingual Pumpspray was approved in 1985. Most patients with angina use sublingual nitroglycerin tablets.

An intranasal formulation of ketorolac tromethamine (Sprix – Lutipold) has been approved by the FDA for short-term (up to 5 days) treatment of moderate to moderately severe pain in adults. It is the first nonsteroidal anti-inflammatory drug (NSAID) to become available in an intranasal formulation. Ketorolac tromethamine is also available in oral, ophthalmic and injectable formulations.

Zolpidem oral spray (Zolpimist – NovaDel/ECR), a new formulation of the oral hypnotic zolpidem tartrate (Ambien, and others), has been approved by the FDA for short-term treatment of insomnia characterized by difficulty falling asleep.

The FDA has approved carfilzomib (Kyprolis – Onyx), a proteasome inhibitor, for intravenous treatment of refractory multiple myeloma. Bortezomib (Velcade) was the first proteasome inhibitor to be approved for this indication.

The FDA has approved the selective alpha₂-adrenergic receptor agonist brimonidine as a 0.33% gel (Mirvaso – Galderma) for topical treatment of adults with persistent facial erythema of rosacea. Brimonidine is also available in ophthalmic formulations for treatment of glaucoma.