[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Notices]
[Pages 51991-51992]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-21227]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-P-0628]


Determination That PENTETATE CALCIUM TRISODIUM (Trisodium Calcium 
Diethylenetriaminepentaacetate) Solution for Intravenous or Inhalation 
Administration, Equivalent to 1 Gram Base/5 Milliliters (Equivalent to 
200 Milligrams Base/Milliliter), Was Not Withdrawn From Sale for 
Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that 
PENTETATE CALCIUM TRISODIUM (trisodium calcium 
diethylenetriaminepentaacetate (Ca-DTPA)) solution for intravenous or 
inhalation administration, equivalent to (EQ) 1 gram (g) base/5 
milliliters (mL) (EQ 200 milligrams (mg) base/mL) was not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
will allow FDA to approve abbreviated new drug applications (ANDAs) for 
PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or 
inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)), if 
all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Alexis Reisin Miller, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6356, Silver Spring, MD 20993-0002, 301-
796-3977.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products under an ANDA procedure. ANDA applicants 
must, with certain exceptions, show that the drug for which they are 
seeking approval contains the same active ingredient in the same 
strength and dosage form as the ``listed drug,'' which is a version of 
the drug that was previously approved. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA). The only clinical data 
required in an ANDA are data to show that the drug that is the subject 
of the ANDA is bioequivalent to the listed drug.
    The 1984 amendments include what is now section 505(j)(7) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which 
requires FDA to publish a list of all approved drugs. FDA publishes 
this list as part of the ``Approved Drug Products With Therapeutic 
Equivalence Evaluations,'' which is known generally as the ``Orange 
Book.'' Under FDA regulations, drugs are removed from the list if the 
Agency withdraws or suspends approval of the drug's NDA or ANDA for 
reasons of safety or effectiveness or if FDA determines that the listed 
drug was withdrawn from sale for reasons of safety or effectiveness (21 
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may 
determine on its own initiative, whether a listed drug was withdrawn 
from sale for reasons of safety or effectiveness. This determination 
may be made at any time after the drug has been withdrawn from sale, 
but must be made prior to approving an ANDA that refers to the listed 
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or 
inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) is the 
subject of NDA 21-749, held by Hameln Pharmaceuticals GmbH, and 
initially approved on August 11, 2004. PENTETATE CALCIUM TRISODIUM (Ca-
DTPA) solution for intravenous or inhalation administration (EQ 1 g 
base/5 mL (EQ 200 mg base/mL)) is indicated for treatment of 
individuals with known or suspected internal contamination with 
plutonium, americium, or curium to increase the rates of elimination.
    In a letter dated June 24, 2010, Hameln Pharmaceuticals GmbH 
notified FDA that PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for 
intravenous or inhalation administration (EQ 1 g base/5 mL (EQ 200 mg 
base/mL)) was being discontinued, and FDA moved the drug product to the 
``Discontinued Drug Product List'' section of the Orange Book.
    Heyl Chemisch-pharmazeutische Fabrik GmbH & Co. KG submitted a 
citizen petition dated November 26, 2010 (Docket No. FDA-2010-P-0628), 
under 21 CFR 10.30, requesting that the Agency determine whether 
PENTETATE CALCIUM TRISODIUM (Ca-DTPA) solution for intravenous or 
inhalation administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) was 
withdrawn from sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency 
records, FDA has determined under Sec.  314.161 that PENTETATE CALCIUM 
TRISODIUM (Ca-DTPA) solution for intravenous or inhalation 
administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) was not withdrawn 
for reasons of safety or effectiveness. The petitioner has identified 
no data or other information suggesting that PENTETATE CALCIUM 
TRISODIUM (Ca-DTPA) solution for intravenous or inhalation 
administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) was withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of PENTETATE CALCIUM 
TRISODIUM (Ca-DTPA) solution for intravenous or inhalation 
administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) from sale. We 
have also independently evaluated relevant literature and data for 
possible postmarketing adverse events. We have found no information 
that would indicate that this product was withdrawn from sale for 
reasons of safety or effectiveness.
    Accordingly, the Agency will continue to list PENTETATE CALCIUM 
TRISODIUM (Ca-DTPA) solution for intravenous or inhalation 
administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) in the 
``Discontinued Drug Product List'' section of the Orange Book. The 
``Discontinued Drug Product List'' delineates, among other items, drug 
products that have been discontinued from marketing for reasons other 
than safety or effectiveness. ANDAs that refer to PENTETATE CALCIUM 
TRISODIUM (Ca-DTPA) solution for intravenous or inhalation

[[Page 51992]]

administration (EQ 1 g base/5 mL (EQ 200 mg base/mL)) may be approved 
by the Agency as long as they meet all other legal and regulatory 
requirements for the approval of ANDAs. If FDA determines that labeling 
for this drug product should be revised to meet current standards, the 
Agency will advise ANDA applicants to submit such labeling.

    Dated: August 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-21227 Filed 8-18-11; 8:45 am]
BILLING CODE 4160-01-P