Enforcement

FDA Warning Letter Confirms DDMAC Focus on Accurate Presentation of Safety Information and Comparative ClaimsApril 25th, 2007
On April 20, 2007, FDA’s Division of Drug Marketing, Advertising, and Communications (“DDMAC”) issued a Warning Letter to Alcon Laboratories, Inc. concerning the company’s promotion of CIPRODEX (ciprofloxacin, 0.3%; dexamethasone, 0.1%) Sterile Otic Suspension in a retail sell sheet and a sales aid. FDA approved …
U.S. ex rel. James Marchese v. Cell Therapeutics, Inc.April 23rd, 2007
On April 16, 2007, Cell Therapeutics, Inc. (“CTI”) agreed to pay $10.5 million to resolve allegations of the company’s illegal marketing of TRISENOX (arsenic trioxide), a prescription drug indicated for treatment of refractory or relapsed acute promyelocytic leukemia. The case arose out of a complaint …
FDA Sets the Stage for an Aggressive Year of Enforcement Action and Issues Warning Letters to Firms Selling Unapproved Ergotamine DrugsMarch 8th, 2007
On March 1, 2007, FDA announced that it issued 20 Warning Letters to companies marketing and distributing unapproved drug products containing ergotamine tartrate, a drug used to treat vascular headaches, including migraines. According to FDA’s press release announcing the enforcement action: In addition to marketing …