[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200 Milligrams Base/Milliliter), Was Not Withdrawn From Sale for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milliliters (mL) (EQ 200 milligrams (mg) base/mL) was not withdrawn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