FDA Approves Pazopanib Tablets
FDA Updates; 04/26/2012
The U.S. Food and Drug Administration approved pazopanib tablets (VOTRIENT®, a registered Trademark of GlaxoSmithKline) for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.
FDA Grants Approval to Everolimus
FDA Updates; 04/26/2012
The U.S. Food and Drug Administration granted accelerated approval to everolimus (Afinitor tablets, Novartis) for the treatment of adults with renal angiomyolipoma, associated with tuberous sclerosis complex (TSC), who do not require immediate surgery.
FDA Announces Action to Bolster Supply of Doxil and Methotrexate
FDA Updates; 02/21/2012
The FDA announces major actions taken to bolster the supply of Doxil® (Janssen Research & Development LLC.) and preservative-free formulations of methotrexate.
FDA Grants Regular Approval for Imatinib Mesylate Tablets
FDA Updates; 01/31/2012
The U.S. Food and Drug Administration (FDA) granted regular approval for imatinib mesylate tablets (Gleevec®, Novartis Pharmaceuticals) for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive Gastrointestinal Stromal Tumors (GIST).
The FDA Approves Vismodegib for Metastatic Basal Cell Carcinoma
FDA Updates; 01/30/2012
The U.S. Food and Drug Administration approved vismodegib (ERIVEDGE™ Capsule, Genentech, Inc.) for the treatment of adults with metastatic basal cell carcinoma or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.
FDA Approves Axitinib Tablets for Advanced Renal Cell Carcinoma
FDA Updates; 01/27/2012
The U.S. Food and Drug Administration approved axitinib tablets (Inlyta, Pfizer, Inc.) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy.
FDA Approves Glucarpidase Injection
FDA Updates; 01/17/2012
The US Food and Drug Administration approved glucarpidase injection (Voraxaze®, BTG International Inc.) for the treatment of toxic plasma methotrexate concentrations (> 1 µmol/L) in patients with delayed methotrexate clearance due to impaired renal function.
FDA Approves Changes to Methotrexate Package Insert
FDA Updates; 12/21/2011
The US Food and Drug Administration has approved changes to the package inserts for methotrexate products for intravenous administration.
FDA Approves Changes to REMS for Romiplostim and Eltrombopag
FDA Updates; 12/06/2011
The Food and Drug Administration (FDA) approved changes to the Risk Evaluation and Mitigation Strategies (REMS) for romiplostim (Nplate for subcutaneous injection, Amgen Inc.) and eltrombopag (Promacta tablets, GlaxoSmithKline LLC) to remove the restricted distribution programs and the safety reporting requirements that were part of the REMS. Prescriber, institution, pharmacy, and patient enrollment and these data collection requirements are no longer necessary.
FDA Approves Asparaginase Erwinia Chrysanthemi for ALL
FDA Updates; 11/18/2011
The US Food and Drug Administration approved asparaginase Erwinia chrysanthemi [ErwinazeTM, injection, EUSA Pharma (USA), Inc.] as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity to E. coli-derived asparaginase.