Released by FDA: 3/16/01. Posted by FDA: 3/28/01
Lifecycle Ventures
c/o
Mark J. Scheineson, Esq.
Reed Smith, L.L.P
1301 K Street, N.W.
Washington, DC 20005
RE: NDA#50-605
Ceftin Tablets(cefuroxime
axetil tablets)
MACMIS ID# 9811
Dear Mr. Scheineson:
As a part of the Division of Drug Marketing, Advertising, and Commumications’ (DDMAC) routine surveillance, we have reviewed promotional materials for Ceflin (cefuroxime axetil) from Lifecycle Ventures submission of FDA form 2253 dated January 01, 2001. The submission contained promotional sales aids for Ceftin (e.g. CEF-0006-A, CEF-0006-P, CEF-0008-P, and CEF-0008-A). We find the sales aids in violation of the Federal Food, Drug, and Cosmetic Act and its applicable regulations. Specifically, we object to the following:
Unapproved Use
 | Ceftin is not approved to treat drug-resistant infections, such as resistant streptococcus pneumonia (PRSP) and resistant haemophilus influenzae. In your sales aids, you promote Ceftin for resistant bacteria with the taglines, “First-line in an era of bacterial resistance,” and “In an era of drug- resistant streptococcus pneumoniae.” These taglines are misleading because they are placed directly in conjunction with treatment and susceptibility information for Acute Otitis Media (AOM), sinusitis, and bronchitis and imply that Ceftin is approved for all listed pathogens, including resistant organisms. The efficacy of Ceftin for the treatment of PRSP arid resistant haemophilus influenzae has not been demonstrated by substantial evidence. Therefore, we find the sales aids to be violative. |
Misleading Economic Claims
| In your sales aids you present “cost-comparisons” between Ceftin and numerous antibiotic regimens for sinusitis, bronchitis, and AOM based on price differences taken from the 2000 Red Book Update (October 2000). You make claims such as, ‘cost-effective” “Ceftin savings,” “manage the expense of treatment,” and “cost of therapy.” These claims are misleading because they are not supported by adequate evidence. These claims imply that all costs associated with therapy have been evaluated, riot simply the acquisition price of the drug. In addition, your graph entitled, “Ceftin savings: A better way to manage the expense of treatment in sinusitis,” is misleading because it implies economic superiority based on the assumption that the outcomes of the different therapies are the same. |
Requested Action
You should immediately cease distribution of the sales aids and other similar promotional materials for Ceftin that contain the same or similar claims or presentations. You should submit a written response on or before March 30, 2001 describing your intent and plans to comply with the above. Your letter should include a list of materials discontinued and the date on which these materials were discontinued.
You should direct your response to the undersigned by facsimile by at (301)594-677l, or to the Food and Drug Administration, Division of Drug Marketing, Advertising, arid Communications, HFD-42, Rm l7-B-20, 5600 Fishers Lane, Rockville, MD 20857. We remind you that only written communications are considered official.
In all future correspondence regarding this particular mailer, please refer to MACMIS ID #9811 in addition to the NDA number.
Sincerely,
James R. Rogers. Pharm.D.
Regulatory Review Officer
Division of Drug Marketing,
Advertising, and Communications
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