These drugs were recently approved by the FDA:
• New indication for tacrolimus (Prograf) by Astellas Pharma US. The FDA has approved tacrolimus (Prograf), a drug that suppresses the body’s immune reaction, for the prevention of graft rejection in the recipients of heart transplants. Tacrolimus capsules and tacrolimus for injection, the first products approved in the United States for heart transplantation in eight years, had been previously approved for the prevention of graft rejection in the recipients of liver and kidney transplants.
Tacrolimus acts by a mechanism similar to cyclosporine, another immunosuppressant used to prevent transplant rejection. Tacrolimus, therefore, offers 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 of which was conducted in Europe and one in the United States. In the European trial, the survival of patients and grafts 18 months after the 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 cyclosporine group (86.1%).
The use of tacrolimus is associated with increased risk or neurotoxicity, renal function impairment, infection, and post-transplant diabetes mellitus. Like most combination immunosuppressive regimens used in solid organ transplantation, the use of tacrolimus-based combination immunosuppression is associated with an increased risk of malignancies, notably of nonmelanoma skin cancers.
• New indication for zanamivir for inhalation (Relenza) by GlaxoSmithKline. The FDA has approved the use of zanamivir for inhalation (Relenza) for prophylaxis of influenza in adults and children 5 years of age and older. Zanamivir, an antiviral medication, was previously approved for the treatment of influenza A and B virus infections in adults and children. Oseltamivir phosphate (Tamiflu) previously was approved for both prevention and treatment of flu; this approval of zanamivir for prevention provides Americans with another option for the prevention of influenza A and B infections.
The effectiveness of zanamivir in preventing seasonal influenza has been demonstrated in four large-scale studies comparing the drug with placebo. In all of these studies, the most common events during treatment with zanamivir in adults and adolescents were ear, nose, and throat infections, headaches; diarrhea, nausea, vomiting, nasal irritation, bronchitis; cough, sinus infections, and dizziness. In children, the most common side effects were ear, nose, and throat infections, vomiting, and diarrhea. Less common reported events included rashes and allergic reactions, some of which were severe.
Bronchospasm, including deaths, were reported in some patients after the initial approval of zanamivir. Most of these patients had asthma or chronic obstructive pulmonary disease. Zanamivir, therefore, is not recommended for treatment or prophylaxis of seasonal influenza in individuals with underlying airways disease such as asthma or chronic obstructive pulmonary disease.
• New capsule form for generic zidovudine by Aurobindo Pharma LTD. The FDA has issued the first generic approval for the capsule dosage form of zidovudine to treat HIV/AIDS to be marketed in the United States. The tablet and oral solution dosage forms of zidovudine were previously approved for sale in the United States when the patent on those dosage forms expired in September 2005. This approval for the capsule formulation of the drug follows the expiration of GlaxoSmithKline’s patent on its capsule form of the product marketed under the trade name Retrovir.
Zidovudine is in the class of drugs called nucleoside reverse transcriptase inhibitors. This antiretroviral drug is intended to be used with other anti-retroviral agents for the treatment of HIV-1 infection.
The agency’s approval of zidovudine means that there are no existing patents and/or exclusivity preventing the approval of generic versions of this product. As with all FDA-approved generics, this product must meet all of FDA’s manufacturing quality, and clinical safety and effectiveness standards for U.S. marketing. More information on HIV and AIDS is available on-line at FDA’s web site: www.fda.gov/oashi/aids/hiv.html.
New indication for tacrolimus (Prograf) by Astellas Pharma US. The FDA has approved tacrolimus (Prograf), a drug that suppresses the bodys immune reaction, for the prevention of graft rejection in the recipients of heart transplants.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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