Drug Criteria & Outcomes

New FDA Approvals

These drugs recently received final approval from the Food and Drug Administration (FDA):

• Capecitabine (Xeloda) by Roche. The FDA has granted approval of capecitabine, the first oral chemotherapy for the treatment of metastatic colorectal cancer. The recommended dose of XELODA is 1250 mg/m2 administered orally twice daily (morning and evening; equivalent to 2500 mg/m2 total daily dose) for two weeks followed by a one-week rest period given as three-week cycles.

• Hepatitis A inactivated and Hepatitis B (recombinant) vaccine (Twinrix) by GlaxoSmithKline. The FDA has granted approval for the vaccine for the prevention of infectious liver disease, hepatitis A, and hepatitis B in adults.

• Carbamezepine (Tegretol) drug products by Novartis Pharmaceuticals Corp. The FDA has granted approval of carbamezepine as an anticonvulsant drug. Tegretol is available in chewable tablets of 100 mg, tablets of 200 mg, and suspension of 100 mg/5 mL. Tegretol-XR is available in 100 mg, 200 mg, and 400 mg extended-release tablets. Tegretol-XR tablets must be swallowed whole and never crushed or chewed.

• Imatinib mesylate (Gleevec) by Novartis Pharmaceuticals Corp. The FDA has granted approval of Imatinib mesylate for the treatment of chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or chronic phase after failure of interferon-alpha therapy. The recommended dosage of Gleevec is 400 mg/day administered orally for patients in chronic phase CML and 600 mg/day for patients in accelerated phase or blast crisis.

• Zidovudine (Retrovir) capsules, syrup, and tablets by GlaxoSmithKline. The FDA has granted approval of zidovudine in combination with other antiretroviral drugs for treatment of HIV infection. The recommended oral dose of Retrovir is 600 mg/day in divided doses in combination with other antiretroviral agents.