New FDA Approvals

These drugs were recently approved by the FDA:

Pravastatin sodium tablets, Teva Pharmaceuticals' generic form of Bristol-Myers Squibbs' Pravachol, indicated for treating individuals with high cholesterol levels or who are at increased risk for atherosclerosis-related cardiac and cardiovascular events such as heart attack and stroke in which high cholesterol levels are a factor.

FDA officials said the approval was an example of agency efforts to counter rising health care costs by approving safe and effective generic alternatives as quickly as the law permits. Pravastatin sodium tablets will be available in 10 mg, 20 mg, and 40 mg doses.

Myozyme (alglucosidase alfa, rhGAA) by Genzyme, indicated for treating Pompe disease, a rare but severely debilitating disease that affects one in 40,000-300,000 individuals, drastically reducing the individual's muscle and respiratory function.

FDA previously granted Myozyme orphan drug designation and gave it priority review. It was approved for administration by intravenous infusion of solution into a vein.

Myozyme's safety and efficacy were assessed in two clinical trials in 39 infantile-onset patients with Pompe disease ranging in age from 1 month to 3.5 years at the time of the first infusion. FDA reported patient survival without needing invasive ventilatory support was substantially greater in the Myozyme-treated infants than would be expected compared to the known high mortality of untreated patients of similar age and disease severity. The drug's safety and effectiveness in other forms of Pompe disease have not been adequately studied, FDA said.

The most serious adverse reactions reported with Myozyme were heart and lung failure and allergic shock. Most common reactions included pneumonia, respiratory failure and distress, infections, and fever. The labeling includes a boxed warning calling attention to the possibility of life-threatening allergic reactions.

Prograf (tacrolimus), Astellas Pharma US, indicated for preventing graft rejection in heart transplant patients. Tacrolimus capsules and tacrolimus for injection, the first products approved in United States for heart transplantation in eight years, previously were approved for preventing graft rejection in liver and kidney transplant recipients.

Company officials said tacrolimus acts by a mechanism similar to cyclosporine, another immunosuppressant used to prevent transplant rejection. Thus, tacrolimus is an alternative to cyclosporine for use in certain combination immunosuppressive regimens in liver, kidney, and heart transplantation.

The safety and effectiveness of tacrolimus-based and cyclosporine-based immunosuppression in heart transplantation were compared in two trials, one in Europe and one in the United States. In the European trial, the survival of patients and grafts 18 months after transplantation in the tacrolimus group (91.7%) was similar to the cyclosporine group (89.8%). In a U.S. study, patient and graft survival at 12 months after transplantation in the tacrolimus group (93.5%) was similar to the cyclo-sporine group (86.1%).

Use of tacrolimus is associated with increased risk of neurotoxicity, renal function impairment, infection, and post-transplant diabetes mellitus. Like most combination immunosuppressive regimens used in solid organ transplantation, use of tacrolimus-based combination immunosuppression is associated with an increased risk of malignancies, notably of non-melanoma skin cancers.

Zidovudine, Aurobindo Pharma's generic form of GlaxoSmithKline's Retrovir, indicated for use with other antiretroviral agents for treating HIV-1 infection. This is the first generic approval for the capsule dosage form of zidovudine. The tablet and oral solution dosage forms were previously approved for sale when the patent on those dosage forms expired last September.