 |
Calcium-DTPA and Zinc-DTPA
FDA approves New Drug Applications for pentetate calcium
trisodium injection (Calcium-DTPA) and pentetate zinc trisodium
injection (Zinc-DTPA) to treat people internally contaminated with
plutonium, americium, or curium.
-
FDA Press Release (issued August 11, 2004)
- Questions and Answers on Calcium-DTPA and
Zinc-DTPA (revised August 11, 2004)
-
Approval Letter (August
11, 2004)
- Pentetate Calcium Trisodium Injection:
Labeling Approved August 11,
2004
- Pentetate Zinc Trisodium Injection: Labeling Approved August 11,
2004
- Calcium-DTPA Draft Labeling (revised August
11, 2004)
- Zinc-DTPA Draft Labeling (revised August
11, 2004)
- Federal Register Notice [HTML]
[PDF]
- Guidance for Industry: Calcium DTPA and Zinc DTPA Drug Products - Submitting a New Drug
Application [Word] or [PDF]
(August 13, 2004)
- FDA Press Release
(issued September 12, 2003)
- Drug Preparedness and Response to
Bioterrorism. This CDER Web page provides links to the most current information on drug therapy and vaccines, plus advice on purchasing and taking medication.
 Back
to Top 
Back to Drug Information
Date created: September 12, 2003; Last updated: August 12, 2004 |
|
