FDA Alerts
Altuzan Counterfeit FDA Warning
FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg / 16ml ( bevacizumab ),an injectable cancer medication, found in the U.S. contains no active ingredient.
FDA Approves Gleevec for Rare Gastrointestinal Cancer
The U.S. Food and Drug Administration granted Gleevec ( imatinib ) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.
Cephalon, Inc. Issues Voluntary Nationwide Recall of Treanda
Cephalon , Inc. is voluntarily recalling Treanda ® ( bendamustine HCL ) for Injection 25mg / 8mL ; lot TB30111 , expiration date 12/2012. This product lot is being recalled due to the presence of particulate matter found in a single vial, which has been identified as glass fragments.
FDA Approves Inlyta to Treat Patients With a Type of Advanced Kidney Cancer
The U.S. Food and Drug Administration today approved Inlyta ( axitinib ) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.
Voraxaze Approved To Treat Toxic Methotrexate Levels
The U.S. Food and Drug Administration approved Voraxaze ( glucarpidase ) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.
FDA Revokes Approval of Breast Cancer Drug
FDA Commissioner Margaret A. Hamburg, MD, said she is revoking the agency’s approval of the breast cancer indication for Avastin ( bevacizumab ) after concluding that the drug has not been shown to be safe and effective for that use.
FDA approves Erbitux to treat late-stage head and neck cancer
The U.S. Food and Drug Administration today approved Erbitux ( cetuximab ) for use with chemotherapy to treat patients with late-stage (metastatic) head and neck cancer.
FDA Approves Prolia for osteoporosis
On September 16, 2011, the U.S. Food and Drug Administration 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.
FDA Alerts: Avastin
The U.S. Food and Drug Administration (FDA) is alerting health care professionals that repackaged intravitreal injections of Avastin ( bevacizumab ) have caused a cluster of serious eye infections in the Miami, Florida area.
FDA Approves Xalkori and Vysis ALK Break Apart FISH Probe Kit
The U.S. Food and Drug Administration today approved Xalkori ( crizotinib ) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers ( NSCLC ) who express the abnormal anaplastic lymphoma kinase ( ALK ) gene.