FDA Alerts

Rx for Rare Metabolic Conditions Approved
Today the U.S. Food and Drug Administration approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).
Trader Joe's Recalls Raw Walnuts
Trader Joe’s Company is recalling Raw Walnuts because these products have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
FDA Warns Against Diet Pill
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Botanical Slimming, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments.
Herb Viagra May Contain Hidden Ingredient
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Herb Viagra, a product promoted for sexual enhancement. This product was identified by FDA during an examination of international mail shipments.
Weight Loss Supplement Contained Hidden Ingredients
The Food and Drug Administration is advising consumers not to purchase or use Lean Body Extreme, a product promoted and sold for weight loss on various websites and in retail stores.
FDA Approves Rx for Neuroblastoma
On March 10, 2015, the U. S. Food and Drug Administration approved dinutuximab (Unituxin, United Therapeutics Corporation), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy.
FDA Approves Farydak for Treatment of Multiple Myeloma
The U.S. Food and Drug Administration today approved Farydak (panobinostat) for the treatment of patients with multiple myeloma.
FDA Permits Marketing of Fecal Incontinence Device for Women
The U.S. Food and Drug Administration today allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women.
FDA Approves Lenvima for a Type of Thyroid Cancer
The U.S. Food and Drug Administration today granted approval to Lenvima (lenvatinib) to treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease).
FDA Approves Rx for Diabetic Retinopathy
The U.S. Food and Drug Administration today expanded the approved use for Lucentis (ranibizumab injection) 0.3 mg to treat diabetic retinopathy (DR) in patients with diabetic macular edema (DME).