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2011 Notifications

To view 2011 Notification information, please see the FDA Archive.
  • FDA has approved changes to the package inserts for methotrexate products for intravenous administration.  Additional information has been added to the WARNING section of the Label.  More Information45 (December 21, 2011)
  • 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. More Information46 (December 6, 2011)
  • FDA approved asparaginase Erwinia chrysanthemi [Erwinaze, 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. More Information47 (November 18, 2011)
  • FDA approved ruxolitinib (Jakafi oral tablets, Incyte Corporation) for the treatment of intermediate and high risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis. Results of two randomized controlled trials in patients with intermediate or high risk myelofibrosis comparing ruxolitinib to placebo (Study 1) or to best available therapy (Study 2) were the basis of approval. 48 (November 16, 2011)
  • FDA approved cetuximab (Erbitux, ImClone LLC, a wholly-owned subsidiary of Eli-Lilly and Company) in combination with platinum-based therapy plus 5-florouracil (5-FU) for the first-line treatment of patients with recurrent locoregional disease and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). More Information49 (November 7, 2011)
  • FDA granted accelerated approval to deferiprone (Ferriprox Tablets, ApoPharma, Inc.), an oral iron chelator for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate. More Information50 (October 14, 2011)
  • Changes in bevacizumab (Avastin, Genentech, Inc.) package insert regarding: risk of ovarian failure, osteonecrosis of the jaw, risk of venous thromboembolic event (VTE) and bleeding in patients receiving anticoagulation therapy after first VTE event. More Information51 (September 30, 2011)
  • FDA granted accelerated approval for the use of eculizumab (Soliris, Alexion, Inc.) for the treatment of pediatric and adult patients with atypical hemolytic uremic syndrome (aHUS).  More Information52 (September 23, 2011)
  • FDA granted approval for denosumab (Prolia, Amgen Inc.) as a treatment to increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer or adjuvant aromatase inhibitor (AI) therapy for breast cancer. In men with nonmetastatic prostate cancer, denosumab also reduced the incidence of vertebral fracture. More Information53 (September 16, 2011)
  • FDA granted accelerated approval to granted accelerated approval to crizotinib (XALKORI Capsules, Pfizer Inc.) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.  The FDA approved the Vysis ALK Break-Apart FISH Probe Kit (Abbott Molecular, Inc.) concurrently with the crizotinib approval.  This companion diagnostic test is designed to detect rearrangements of the anaplastic lymphoma kinase (ALK) gene in NSCLC. More Information 54 (August 26, 2011)
  • FDA granted accelerated approval to brentuximab vedotin (Adcetris for Injection, Seattle Genetics, Inc.) for two indications: (1) treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates and (2) treatment of patients with systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent chemotherapy regimen.  More Information55 (August 19, 2011)
  • FDA approved vemurafenib tablets (ZELBORAF, Hoffmann-La Roche Inc.) for the treatment of patients with unresectable or metastatic melanoma with the BRAFV600E mutation as detected by an FDA-approved test.  More Information56 (August 17, 2011) 
  • FDA approved sunitinib (Sutent Capsules, Pfizer, Inc.) for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable, locally advanced, or metastatic disease. More Information57 (May 20, 2011)
  • FDA approved everolimus (Afinitor Tablets, Novartis Pharmaceuticals Corporation), for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease.  The safety and effectiveness of everolimus in the treatment of patients with carcinoid tumors have not been established. More Information58 (May 5, 2011)
  • FDA approved abiraterone acetate (Zytiga Tablets, Centocor Ortho Biotech, Inc.) for use in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have received prior chemotherapy containing docetaxel.  More Information 59 (April 28, 2011) 
  • FDA approved vandetanib tablets (Vandetanib Tablets, AstraZeneca Pharmaceuticals LP), a kinase inhibitor, for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable, locally advanced, or metastatic disease. The use of vandetanib in patients with indolent, asymptomatic or slowly progressing disease should be carefully considered because of the treatment-related risks of vandetanib.  More Information60 (April 6, 2011)
  • FDA approved peginterferon alfa-2b (Sylatron, Schering Corporation, Kenilworth, NJ 07033), for the treatment of patients with melanoma with microscopic or gross nodal involvement within 84 days of definitive surgical resection including complete lymphadenectomy. More Information61 (March 29, 2011)
  • FDA approved ipilimumab injection (YERVOY, Bristol-Myers Squibb Company) for the treatment of unresectable or metastatic melanoma.  More Information 62. (March 25, 2011)
  • FDA approved rituximab (Rituxan, Genentech, Inc) for maintenance therapy for patients with previously untreated follicular, CD-20 positive, B-cell non-Hodgkin lymphoma who achieve a response to rituximab in combination with chemotherapy. More Information63 (January 28, 2011)


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