New FDA Approvals

These drugs have received final approval from the Food and Drug Administration:

• Antibiotic levofloxacin (Levaquin) by Ortho-McNeil Pharmaceutical Inc. New indication for levofloxacin tablets and injection to treat complicated skin and skin structure infections at a dose of 750 mg once daily. This is a new, higher dose.

 

• Anticancer agent arsenic trioxide (Trisenox) injection by Cell Therapeutics Inc. for induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy and whose APL is characterized by presence of the t(15;17) translocation or PML/RAR-alpha gene expression. New therapy has orphan drug status, with 1,500 new cases of APL diagnosed each year, of which an estimated 400 patients will not respond to, or will relapse from, first-line therapy.

 

• Asthma agent beclomethasone dipropionate HFA (Qvar) 40 mcg and 80 mcg Inhalation Aerosol by 3M Pharmaceuticals for the maintenance treatment of asthma as prophylactic therapy. Also indicated for asthma patients who require systemic corticosteroid administration, where adding QVar may reduce or eliminate the need for the systemic corticosteroids.

 

• Antiretroviral lopinavir/ritonavir (Kaletra) by Abbott Laboratories. Accelerated approval to market the drug for treatment of HIV-1 infection in adults and children 6 months and older in combination with other antiretroviral medications. This is the only protease inhibitor approved for use in children as young as 6 months. Lopinavir is a protease inhibitor; ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby increasing plasma levels of lopinavir. The combination is available as capsules (400 mg lopinavir/100 mg ritonavir) and oral solution (80 mg lopinavir/20 mg ritonavir).