FDA Approvals, News & Updates

The US Food and Drug Administration (FDA) today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.
  • First HDAC Inhibitor, Panobinostat, Approved for the Treatment of Patients with Multiple Myeloma
  • Palbociclib Approved for Metastatic Breast Cancer in Postmenopausal Women
  • FDA Expedites Approval of Lenvatinib for Refractory Differentiated Thyroid Cancer
  • Lenalidomide plus Dexamethasone Receives Expanded Indication for Patients with Newly Diagnosed Myeloma
  • Nivolumab First Immuno­therapy to Get FDA Approval for Metastatic Lung Cancer
A Payers’ Guide to New FDA Approvals is published annually by American Health & Drug Benefits to offer payers and other healthcare stakeholders a detailed analysis of new drugs approved by the US Food and Drug Administration (FDA) in the previous year, as well as a preview of some of the key trends in the 2015 drug pipeline.
On January 8, 2014, the US Food and Drug Administration (FDA) approved the use of dabrafenib (Tafinlar; GlaxoSmithKline) plus trametinib (Mekinist; GlaxoSmithKline) as a new combination therapy for the treatment of patients with advanced melanoma that is unresectable or metastatic.
On January 12, 2014, the FDA approved a new indication for ibrutinib (Imbruvica; Pharmacyclics) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least 1 previous therapy, using the agency’s accelerated approval process.
On April 17, 2014, the FDA approved ofatumumab (Arzerra Injection; Glaxo­SmithKline), in combination with chlorambucil, for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate.
On April 21, 2014, the FDA approved ramucirumab (Cyramza; Eli Lilly) for the treatment of patients with advanced stomach cancer or gastro­esophageal junction adenocarcinoma.
On April 29, 2014, the FDA approved ceritinib (Zykadia; Novartis) for the treatment of patients with metastatic, anaplastic lymphoma kinase (ALK)-positive non–small-cell lung cancer (NSCLC).
On May 28, 2014, the FDA approved a new indication for palonosetron HCl (Aloxi; Eisai) injection for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) associated with initial or repeated courses of emetogenic chemotherapy in children aged 1 month to
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