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

Description

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.

• 21CFR314.50§ 314.50 Content and format of an NDA.

  NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →

• 21CFR314.108§ 314.108 New drug product exclusivity.

  (a) Definitions. The definitions in § 314.3 and the following definitions of terms apply to this section:Read full regulation →

• 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.

  (a) Filing an NDA.Read full regulation →

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