Tag Archives: FDA

FDA Issues Final Guidance on Proprietary Names for Drugs and Biological Products

Dozens of prescription medicine bottles in a jumble. This collection of pill bottles is symbolic of the many medications senior adults and chronically ill people take.

The Food and Drug Administration (FDA) has finalized guidance for industry describing the agency’s evaluation process for proposed proprietary names for drug and biological products.  The guidance applies to all prescription and nonprescription drug products, innovator and generic drug products, and biological products.  Drug products that may be legally marketed without an approved application are excluded (e.g., OTC drugs legally marketed under a tentative or final monograph). … More

Milk Dud? False Advertising Lawsuit Against Makers of Muscle Milk Illustrates Interplay Between Lanham Act, FTC and FDA

MM1In a lawsuit recently filed in the Southern District of Florida, Global Beverage Enterprises, Inc. (“Global”), the manufacturer of specialty carbonated beverages like Mr. Q. Cumber Sparkling Cucumber Beverage, brought Lanham Act claims against CytoSport, Inc., alleging false advertising of CytoSport’s popular Muscle Milk line of beverages.  The basis of the claim is that the Muscle Milk beverages contain no milk and, therefore, the product name is false and misleading. … More