FDA Drug Approvals, January–April 2012


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  • FDAlogoImatinib mesylate tablets (Gleevec) approved for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST).
  • Vismodegib capsules (Erivedge) approved for the treatment of metastatic basal cell carcinoma or locally advanced basal cell carcinoma. 
  • Axitinib tablets (Inlyta) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.
  • Glucarpidase  injection (Voraxaze) for the treatment of toxic plasma methotrexate concentrations (> 1 μmol/L) in patients with delayed methotrexate clearance due to impaired renal function.

For more information, visit fda.gov.



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