The FDA has recently approved RotaTeq (Merck), an oral live, human-bovine reassortant rotavirus vaccine, for use in infants to prevent rotavirus gastroenteritis, a frequent cause of severe diarrhea in infancy.

Two cholesterol-lowering margarines have been marketed in the USA.

Sirolimus, whlch is structurally related to tacrolimus, has been approved by the FDA for prevention of acute renal transplant rejection. The manufacturer recommends that sirolimus be taken with cyclosporine and corticosteroids.

The FDA has approved an extended-release (XR) formulation of the benzodiazepine alprazolam (Xanax XR - Pfizer) for treatment of panic disorder, with or without agoraphobia. The new formulation is intended to reduce the need for frequent dosing and problems of interdose anxiety. This review describes the effectiveness of the extended-release formulation, as well as sections on dependence, abuse and withdrawal, adverse effects, and drug interactions. The review concludes with an overall assessment of the drug's efficacy and cost.

The FDA has approved an extended-release formulation of amoxicillin (Moxatag – MiddleBrook) for once-daily treatment of pharyngitis or tonsillitis caused by Streptococcus pyogenes in adults and children ≥12 years old. Approval was based on an unpublished study that found once-daily treatment with Moxatag 775 mg for 10 days non-inferior to penicillin V 250 mg four times a day for 10 days in eradication of S. pyogenes.For decades, the drug of choice for oral treatment of streptococcal pharyngitis in adolescents and adults has been penicillin V 250 mg taken three or four times a day.1...

The injectable direct thrombin inhibitor desirudin (Iprivask – Canyon), a recombinant analog of hirudin, the leech anticoagulant protein, was approved by the FDA in 2003 for prevention of venous thromboembolism (VTE) after elective hip arthroplasty, but was only marketed recently in the US. It has been available in Europe as Revasc for about 10 years. Two other hirudin analogs are available in the US: lepirudin (Refludan) for treatment of heparin-induced thrombocytopenia (HIT) and bivalirudin (Angiomax) for use in percutaneous coronary intervention (PCI).

Emrosi (Journey), an oral, low-dose, biphasic-release formulation of the tetracycline antibiotic minocycline, has been approved by the FDA for once-daily treatment of inflammatory lesions of rosacea (papules and pustules) in adults. Low-dose, biphasic-release doxycycline (Oracea, and generics) has been available for years for treatment of papulopustular rosacea.

Levodopa combined with carbidopa (Sinemet) is the treatment of choice for Parkinson's disease (Medical Letter, 30:113, 1988). After prolonged treatment, however, the symptoms of the disease often become difficult to manage. The benefit from each dose becomes shorter (the 'wearing-off' effect), sudden fluctuations occur between mobility and immobility (the 'on-off' phenomenon), and abnormal involuntary movements (dyskinesias) may become frequent. The dopamine agonist bromocriptine (Parlodel) can ameliorate some of these effects. Two new drugs, pergolide (Permax - Lilly), another dopamine...

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.

Nitazoxanide (Alinia - Romark Labs), a new antiparasitic drug, has been approved by the FDA in a liquid formulation for treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia in children 1 to 11 years old. It is the first drug approved for treatment of cryptosporidiosis and the first to become available as a liquid for treatment of giardiasis. The FDA is reviewing a tablet formulation of nitazoxanide for use in adults.