1. Proprietary Names and the Drug Approval Process John K. Jenkins, M.D., F.C.C.P. Director, Officer of New Drugs Center for Drug Evaluation and Research June 26, 2003

2. Review of Proprietary Names Review performed by OND in consultation with other CDER offices/divisions –Office of Drug Safety/DMETS –Office of Medical Policy/DDMAC –Joint review with CBER in some cases Primary areas of focus –Safety - prevent medication errors –Promotion - “fanciful” names, false and/or misleading claims

3. Regulations 21 CFR 210.10(c.) “The labeling of a drug may be misleading by reason (among other reasons) of: –(3) “The employment of a fanciful proprietary name for a drug or ingredient in such a manner as to imply that the drug or ingredient has some unique effectiveness or composition when, in fact, the drug or ingredient is a common substance, the limitations of which are readily recognized when the drug or ingredient is listed by its established name.”

4. Regulations (cont.) 21 CFR 210.10 (c.) “The labeling of a drug may be misleading by reason (among other reasons) of: –(5) “The designation of a drug or ingredient by a proprietary name that because of similarity in spelling or pronunciation, may be confused with the proprietary name or the established name of a different drug or ingredient.”

5. Proprietary Names - Safety Focus of review - avoid medication errors Confusion regarding drug names and/or packaging can lead to medication errors OND in consultation with ODS/DMETS reviews the proposed proprietary name for “sound-alike” and/or “look-alike” similarities to approved/marketed proprietary names and established names

6. Proprietary Names - Promotion Focus of review - “fanciful” names, false and/or misleading claims embedded in name; e.g., –Superiority claims –Claims for different or expanded indications –Claims for efficacy or safety not supported by data OND in consultation with OMP/DDMAC reviews the proposed proprietary name for embedded false and/or misleading claims

7. Proprietary Names - Other Issues Suffixes –Often confusing with overlapping meanings; e.g., SR, CR, XL, XR, CD –May include implied claims; e.g., XL (excellent?, better than other products?) –May be misinterpreted as a dosing schedule (e.g., QD, BID) May have been appropriate at time of original approval, but may not be correct with later updates to labeling claims and D&A section

8. Proprietary Names - Other Issues Multiple proprietary names for products with same active ingredient –Potential for confusion, overdosing –Generally discouraged; have been allowed in certain cases Same proprietary name for different active ingredients –“Family” trade names for OTC products (e.g., Tylenol, Robitussin, Maalox)

9. Review Process Preliminary review during IND (EOP2) Early Agency feedback may change due to approval of other products in the interim Proprietary name is not approved until it is approved –DMETS final review within 90 days of approval –DDMAC final review may be impacted by final decisions on indications, labeling Final decision rests with OND

10. Suggestions to Sponsors Do your homework to avoid problems Begin consultation with FDA early –Understand preliminary nature of advice at early stages Avoid embedded implied claims that are not supported by substantial evidence Consider submitting more than one name for review; have backups ready Work cooperatively to resolve concerns