The FDA has approved Gimoti (Evoke), a nasal spray formulation of the dopamine-2 (D₂) receptor antagonist metoclopramide, for relief of symptoms in adults with acute and recurrent diabetic gastroparesis. Metoclopramide (Reglan, and generics) has been available for years in conventional and orally-disintegrating tablets and in an injectable formulation. It is the only drug that is FDA-approved for treatment of diabetic gastroparesis.

Rosacea is a common, chronic inflammatory facial eruption of unknown cause. It is more prevalent in women than in men, and disease onset typically occurs after age 30. Rosacea is characterized by erythema, telangiectasia, and flushing, and sometimes by recurrent, progressive crops of acneiform papules and pustules, usually on the central part of the face. Some patients develop granulomas and tissue hypertrophy, which may lead to rhinophyma (a bulbous nose), particularly in men. Blepharitis and conjunctivitis are common. Keratitis and corneal scarring occur rarely.

Gastroesophageal reflux disease (GERD) is the most common GI condition encountered in the outpatient setting; it affects about 20% of people in the US.

Azelaic acid 15% gel (Finacea Berlex) is now available in the US for treatment of mild to moderate rosacea. A 20% cream formulation of the drug (Azelex Allergan; Medical Letter 1996; 38:52) has been marketed here since 1996 for treatment of acne. The effectiveness of Finacea compared to its own vehicle and to metronidazole gel is discussed. Information on the drug's mechanism of action, adverse effects, dosage and cost are also included.

Cefdinir (Omnicef - Parke-Davis), a third-generation oral cephalosporin, has been approved by the FDA for treatment of acute sinusitis, otitis media, acute exacerbations of chronic bronchitis, pharyngitis, community-acquired pneumonia and skin infections. Other drugs available for these indications are reviewed in The Medical Letter Handbook of Antimicrobial Therapy, 1998.

Gatifloxacin and moxifloxacin are now available for once-daily treatment of patients with community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, or acute sinusitis.

The FDA has approved loteprednol etabonate ophthalmic suspension 0.25% (Eysuvis – Kala) for short-term treatment (≤2 weeks) of dry eye disease. It is the first ocular corticosteroid to be approved for this indication. Other formulations of loteprednol are approved for treatment of steroid-responsive ocular inflammatory conditions, inflammation after ocular surgery, and seasonal allergic conjunctivitis.

Lansoprazole (Prevacid -TAP), a proton pump inhibitor similar to omeprazole (Prilosec - Medical Letter, 32:19, 1990), has been approved by the US Food and Drug Administration for short-term treatment of active duodenal ulcer and erosive reflux esophagitis and for long-term treatment of chronic hypersecretory conditions, including the Zollinger-Ellison syndrome.

Cefepime hydrochloride (Maxipime - Bristol-Myers Squibb), a new 'fourth-generation' cephalosporin, has been approved by the US Food and Drug Administration (FDA) for parenteral treatment of urinary tract infections and skin and skin-structure infections due to susceptible pathogens, and for moderate to severe pneunmonia caused by Streptococcus pneumoniae (pneumococci), Pseudomonas aeruginosa, Enterobacter or Klebsiella pneumoniae.

The FDA has approved raxibacumab (rax” ee bak’ ue mab; GSK), a fully human monoclonal antibody given by intravenous infusion, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. It was approved under the Animal Efficacy Rule, which allows the FDA to approve drugs that demonstrate efficacy in animals, providing that they would have a reasonable human health benefit and are safe for human use. Raxibacumab is only available from the...