Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug Application August 2004
- Docket Number:
- None found
- Issued by:
Guidance Issuing OfficeCenter for Drug Evaluation and Research
This guidance is intended to assist manufacturers wishing to submit new drug applications (NDAs) for pentetate calcium trisodium (Ca-DTPA) and pentetate zinc trisodium (Zn-DTPA) drug products for the treatment of individuals with known or suspected internal contamination with plutonium, americium, or curium. In the Federal Register of September 15, 2003 (68 FR 53984), we announced the availability of this guidance, explained in detail our findings regarding safety and effectiveness, and included a list of citations to the literature on which we partially based those findings. Draft product labeling was prepared for Ca-DTPA supplied as 1 g in a 5 mL sterile aqueous solution for administration either by inhalation (with a 1:1 dilution with saline and delivered by nebulization) or intravenous injection. Draft product labeling was also prepared for Zn-DTPA supplied as 1 g in a 5 mL sterile aqueous solution for intravenous injection.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: None found.