DDMAC untitled letters.The following untitled letters were issued by the Centers for Drugs' Division of Drug Marketing, Advertising and Communications (DDMAC DDMAC Division of Drug Marketing, Advertising and Communications ). Copies are available from our RECORD-RETRIEVE service for $7 plus retrieval. Please reference the MACMIS ID # to order the company response. 11945W Biovail Pharmaceuticals, Chantilly, VA, Aug. 22 (DDMAC). Promotional materials for the firm's product Cedax (ceftibuten) overstate the efficacy of the product, according to the letter. Specifically, DDMAC took issue with a tag line in the promo stating "Hard to resist," stating the tag line suggesting that Cedax was "effective against drug-resistant pathogens." The letter warned that this suggestion could lead physicians to inappropriately prescribe the product and contribute to antibiotic resistance in pathogens. ID# 10744 11946W Forest Laboratories, Inc., Jersey City, NJ, Sept. 13 (DDMAC). FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. took issue with some 28 pages of promotional material for the firm's Celexa (citalopram citalopram /ci·tal·o·pram/ (si-tal´o-pram) 1. an antidepressant compound used in the treatment of major depressive disorder, administered orally as the hydrobromide. 2. HBr) antidepressant stating that the material was misleading and lacked fair balance. Specifically, the letter cited four comparative claims with paroxetine paroxetine /par·ox·e·tine/ (pah-rok´se-ten) a selective serotonin uptake inhibitor used as the hydrochloride salt to treat depression and obsessive-compulsive, panic, and social anxiety disorders. "based on clinical trials that do not use a placebo control [and] are therefore misleading because they are not adequately substantiated." Also, the agency stated that the materials understated "one of the most important" sets of adverse events associated with the drug, namely, gastrointestinal events. ID# 10853 F-B F-B Forward - Backward (radar image analysis) 11947W Pfizer, New York, NY, Sept. 3 (DDMAC). The letter objected to claims made by the firm in promotional materials and at a promotional booth for its Geodon (ziprasidone HCl) anti-psychotic drug. In promotional materials, the firm minimized important risk information "regarding the greater capacity of Geodon to cause QT prolongation, and the potential to cause torsade tor·sade n. A decorative trimming of twisted ribbon or cord, used especially on hats. [French, from tors, from Vulgar Latin *torsus, alteration of Latin tortus de pointes-type arrhythmia and sudden death," the agency stated. Also, at the annual meeting of the American Psychiatric Assn. in May, FDA stated that "Pfizer representatives minimized important risk information regarding the greater capacity of Geodon to cause QT prolongation and the potential to cause sudden death, and misrepresented Geodon as having antidepressant effects similar to the selective serotonin reuptake inhibitors Selective Serotonin Reuptake Inhibitors Definition Selective serotonin reuptake inhibitors are medicines that relieve symptoms of depression. Purpose ." ID# 10790 F-B |
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