Dentsply has a few more hours to submit their reply to the Food and Drug Administration on whether they will comply.
TRANSMITTED BY FACSIMILE
Bret W. Wise
Chairman and Chief Executive Officer
221 W. Philadelphia Street
York, PA 17405-0872
RE: NDA 021451
Oraqix ® (lidocaine and prilocaine periodontal gel) 2.5% / 2.5%
MACMIS # 18658
Dear Mr. Wise:
Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed two professional direct mailers (PHA01-0509-1; PHA01-0509-2)
(direct mailers), and a professional journal advertisement (PHA01-0509-3) (journal ad) for Oraqix® (lidocaine and prilocaine periodontal gel) 2.5%/2.5% (Oraqix) submitted by DENTSPLY Pharmaceutical(Dentsply) under cover of Form FDA 2253. The direct mailers and journal ad are false or misleading because they omit and minimize risk information associated with Oraqix, make unsubstantiated superiority claims, overstate the efficacy, and broaden the indication of the drug.
The direct mailers and journal ad therefore misbrand the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a) & (n); 321(n). See 21 CFR 202.1(e)(5); (e)(6)(i) & (ii); and (e)(7)(viii).
Conclusion and Requested Action
For the reasons discussed above, the direct mailers and journal ad misbrand Oraqix in violation of the Act, 21 U.S.C. 352(a) & (n); 321(n). See 21 CFR 202.1(e)(5); (e)(6)(i) & (ii); and (e)(7)(viii).
DDMAC requests that Dentsply immediately cease the dissemination of violative
promotional materials for Oraqix such as those described above. Please submit a written response to this letter on or before January 19, 2011, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Oraqix that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials. Because the violations described above are serious, we request, further, that your
submission include a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials. Please direct your response to me at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD 20705-1266, or facsimile at 301-847-8444. In all future correspondence regarding this matter, please refer to MACMIS 18658 in addition to the NDA number. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Oraqix comply with each applicable requirement of the Act and FDA implementing regulations.
Failure to correct the violations discussed above may result in FDA regulatory action, including seizure or injunction, without further notice.