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GUIDANCE DOCUMENT

Calcium DTPA and Zinc DTPA Drug Products-Submitting a New Drug Application August 2004

Final
Issued by:
Guidance Issuing Office
Center 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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.