FDA Actions

摘要

1. The U.S. Food and Drug Administration (FDA) has obtained a permanent injunction against Scientific Laboratories Inc. The firm is barred from making and distributing drug products until its manufacturing operations comply with law and its products are FDA approved. The unapproved new drugs Scientific Laboratories marketed as prescription cough and cold products include the following: B-Vex Suspension, Ben-Tann Suspension, D-Tann (AT, CT, HM, DC) Suspensions, Dur-Tann DM Suspension, Duratan DM Suspension, L-All 12 Suspension, Nazarin Liquid, and HC Liquid. 2. The FDA has announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin), to address the increased risk of cancer mortality for individuals who use three or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.