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.
Allergan, Irvine, CA, June 8 (DDMAC). The agency wrote up the firm because a sales aid for Lumigan (bimatoprost ophthalmic) failed to present information on the product's side effects and contraindications, including the risk of increased pigmentation of the iris and periorbital tissue, including the eyelid. FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. wrote that the sales aid included a presentation of data for the product's effect on IOP IOP
IOP Intraocular pressure, see there (intra-ocular pressure) adjacent to such information for Xalatan (latanoprost) and Travatan (travapost) that suggested the products' relative efficacy had been studied in head-to-head evaluations when such was not the case. The letter added that a disclaimer that "data taken from separate comparable studies does not imply head-to-head comparisons" did not negate the "misleading message" provided by the table. ID # 10055 F-B F-B Forward - Backward (radar image analysis)
Alza, Mountain View, CA, June 28 (DDMAC). The letter cited a commercial exhibit at a meeting of the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO ASCO American Society of Clinical Oncology
ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland)
ASCO Australian Standard Classification of Occupations
ASCO Automatic Switch Company ) that FDA stated minimized the side effects of Doxil (doxorubicin HCL HCl
hydrochloric acid. ) by handing out hairbrushes and explaining to attendees that "you don't lose your hair with Doxil." The agency insisted that approved product labeling included the statement that alopecia alopecia (ăl'əpē`shēə): see baldness. occurred in roughly 15% of ovarian cancer patients and approximately 9% of Kaposi's sarcoma patients using the drug. ID # 10140
Alza, Mountain View, CA, July 12 (DDMAC). FDA hit Alza with a second untitled letter for Ditropan (oxybutynin CL) since Nov. 16 (Doc. 9773W), this one for a broadcast ad that the agency insisted was "misleading because it fails to adequately convey the symptoms of overactive bladder." The letter indicated that the symptoms were presented too briefly to be comprehended by viewers. ID # 10196
AstraZeneca Pharmaceuticals, Wilmington, DE, July 9 (DDMAC). The agency cited the firm for promoting Arimidex (anastrozole) for an unapproved use because an abstract distributed at an ASCO meeting stated that therapeutic effects included a "dramatic reduction of E2 levels in post-menopausal women" using the drug without therapies. FDA wrote that the disclaimer "for medical information only
not approved in the U.S." did not mitigate the violative promotion. ID # 10135
Aventis Pharmaceuticals, Bridgewater, NJ, June 25 (DDMAC). The letter stated that a convention panel for Lovenox (enoxaparin sodium) failed to provide information regarding side effects and contraindications, including spinal and epidural hematomas. ID # 10148
Bayer Corp., West Haven, CT, June 6 (DDMAC). FDA hit the company for promoting vardenafil, an investigational new drug, at a convention of the American Urological Association. ID # 10099 NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any
Bayer Corp., West Haven, CT, June 29 (DDMAC). The letter stated that Bayer promoted Avelox (moxifloxacin) for treatment of penicillin-resistant Streptococcus pneumoniae, an unapproved use, at a meeting of the American Society of Health-System Pharmacists The American Society of Health-System Pharmacists (ASHP) is a professional organization representing the interests of pharmacists who practice in hospitals, health maintenance organizations, long-term care facilities, home care, and other components of health care systems. . ID # 10160
Berlex Labs, San Pablo, CA, June 28 (DDMAC). The firm was hit for promoting Fludara (fludarabine phosphate) for primary treatment of chronic lymphocytic leukemia chronic lymphocytic leukemia
n. Abbr. CLL
Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms. when the drug was approved for the disease only when a patient had not responded to or whose disease had worsened during treatment with a regime including at least one alkylating agent. ID # 10154
Bristol-Myers Squibb, Plainsboro, NJ, July 20 (DDMAC). The agency zapped Bristol for promoting an investigational new drug, UFT UFT United Federation of Teachers
UFT Tegafur-Uracil (chemotherapy)
UFT Unified Field Theory (physics)
UFT Undergraduate Flying Training
UFT Unofficial Foreign Travel
UFT Up for Trade (uracil uracil (yr`əsĭl), organic base of the pyrimidine family. It was isolated from herring sperm and also produced in a laboratory in 1900–1901. and tegafur), at an ASCO convention. ID # 10137
Genzyme, Cambridge, MA, July 13 (DDMAC). A DTC DTC
See: Depository Transfer Check
See: Depository Trust Company
See Depository Trust Company (DTC). radio ad took a citation for Cerezyme (imiglucerase) because the ad minimized the probability that the patient would experience "a variety of local reactions at the site of the injection." ID # 10172 DTC
GlaxoSmithKline, Philadelphia, PA, July 28 (DDMAC). The agency hit the firm for a DTC broadcast ad for Avandia (rosiglitazone maleate) for the superimposed su·per·im·pose
tr.v. su·per·im·posed, su·per·im·pos·ing, su·per·im·pos·es
1. To lay or place (something) on or over something else.
2. text "Avandia-Help use the natural insulin in you," because the super presented consumers with "conflicting messages" regarding the drug's contraindication contraindication /con·tra·in·di·ca·tion/ (-in?di-ka´shun) any condition which renders a particular line of treatment improper or undesirable.
n. for concurrent use of insulin. ID # 10171 DTC
The following symbols are used to flag certain warning letters containing alleged violations of specific FDA regulations and policies of current interest:
API Active pharmaceutical ingredients BiMo Monitoring, IRB, investigator issues BSE Bovine spongiform encephalopathy issues Cal Calibration C-H Complaint handling CAPA Corrective and preventive action Comp-Soft Computer software validation Design Design validation activities DTC Direct-to-consumer advertising violations DSHEA Labeling that exceeds 'structure/function claims for dietary supplements F-B Lack of fair balance in promotion LAB Labeling issues MDR Medical device reporting NDA New drug application NLEA Labeling that violates the Nutritional Labeling and Education Act OL-Use Promoting a drug for unapproved uses PMA Lack of premarket approval QC/QS QC/quality systems deviations S-HACCP Violations of HACCP requirements for seafoods Stab Stability Ster Sterility Val Validation Web Internet promotion irregularities
GlaxoSmithKline, Philadelphia, PA, July 28 (DDMAC). Glaxo was zapped for a presentation at the ASCO meeting for Navelbine (vinorelbine tartrate) because of the statement that patients taking the drug "don't feel like they received chemotherapy," a claim FDA insisted was substantiated by supporting evidence and was inconsistent with product labeling. ID # 10153
Janssen Research Foundation, Titusville, NJ, June 27 (DDMAC). Janssen's promotion of Sporanox (itraconazole itraconazole /it·ra·co·na·zole/ (it?rah-kon´ah-zol) a triazoleantifungal used in a variety of infections.
n. ) at a meeting of the American Society of Health-System Pharmacists was deemed violative because a representative stated that the drug had no hepatic effect and denied any cardiac risk despite warnings for both effects in product labeling. ID # 10159
Merck, North Wales, PA, July 19 (DDMAC). The letter stated that a representative offered to send attendees at the ASCO meeting information about off-label use for Cancidas (caspofungin acetate) and that receipt of the information showed the firm intended the product to be applied in unapproved uses. ID # 10161 OL-Use
Merck., North Wales, PA, July 20 (DDMAC). The firm's Web site was cited for overstating the benefits of Fosamax (alendronate sodium) because of a hyperlink for a page called "Preserving Your Independent Lifestyle" appearing on a sidebar with information on the main part of the Web page listing patient information. ID # 9727 Web
Pfizer, New York, NY, June 29 (DDMAC). FDA wrote that a "slim jim" for Neurontin (gabapentin) claimed improvement in social limitations, memory difficulties, energy level and work limitations based on an uncontrolled study. ID # 10174
Pfizer, New York, NY, July 12 (DDMAC). Pfizer's journal ad for Lipitor (atorvastatin atorvastatin /ator·va·stat·in/ (ah-tor?vah-stat´in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used as the calcium salt in the treatment of hypercholesterolemia and other forms of dyslipidemia. ) was cited for lack of fair balance due to presentation of risk information "in small type on the bottom" of the page and lack of any "header or signal to alert readers to its importance." ID # 9607 F-B
PharmaMar, USA, Cambridge, MA, June 25 (DDMAC). The agency hit the firm for promotion of an investigational new drug, ecteinasicidin-743, at an ASCO meeting. ID # 10136
Sanofi Synthelabo, New York, NY, June 8 (DDMAC). The agency issued the firm a second untitled letter since May 9 (Doc. 10452W) for Plavix (clopidogrel bisulfate), this one for a DTC ad that "minimizes the role of the doctor in determining whether Plavix is the appropriate medication." FDA insisted that the superimposed text directing patients to "talk to your doctor" lacked the needed context to communicate that the physician was a source of product information. ID # 10107 DTC
Schering Corp., Kenilworth, NJ, June 28 (DDMAC). FDA hit the firm for promoting Temodar (temozolomide) as a first-line therapy for anaplastic an·a·plas·tic
1. Relating to the surgical restoration of a lost or absent part.
2. Of, relating to, or characterized by cells that have become less differentiated.
1. astrocytoma astrocytoma /as·tro·cy·to·ma/ (as?tro-si-to´mah) a tumor composed of astrocytes; the most common type of primary brain tumor and also found throughout the central nervous system, classified on the basis of histology or in order of at an ASCO meeting and for presenting the drug as comparing favorably with placebo for improved survival when approved product labeling indicated that no such data from randomized ran·dom·ize
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment. trials demonstrated improved survival rates over placebo. ID # 10141