[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Page 37129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-15815]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0428]


Determination That SODIUM FLUORIDE F 18 (Sodium Fluoride F-18) 
Injection, 10 to 200 Millicuries per Milliliter, Was Not Withdrawn From 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 
SODIUM FLUORIDE F 18 (sodium fluoride F-18) injection, 10 to 200 
millicuries per milliliter (mCi/mL), was not withdrawn from sale for 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 SODIUM 
FLUORIDE F 18 injection, 10 to 200 mCi/mL, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:  Reena Raman, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6238, Silver Spring, MD 20993-0002, 301-
796-7577.

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 
(Sec.  314.162 (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 
(21 CFR 314.161). FDA may not approve an ANDA that does not refer to a 
listed drug.
    SODIUM FLUORIDE F 18 (sodium fluoride F-18) injection, 10 to 200 
mCi/mL, is the subject of NDA 22-494, held by National Cancer 
Institute, National Institutes of Health, and initially approved on 
January 26, 2011. SODIUM FLUORIDE F 18 (sodium fluoride F-18) is 
indicated for diagnostic positron emission tomography imaging of bone 
to define areas of altered osteogenic activity.
    The NDA holder has never marketed SODIUM FLUORIDE F 18 (sodium 
fluoride F-18) injection, 10 to 200 mCi/mL, and in a letter dated May 
2, 2011, the NDA holder requested that FDA move the product to the 
``Discontinued Drug Product List'' section of the Orange Book. In 
previous instances (see, e.g., 72 FR 9763, March 5, 2007; 61 FR 25497, 
May 21, 1996), the Agency has determined that, for purposes of 
Sec. Sec.  314.161 and 314.162, never marketing an approved drug 
product is equivalent to withdrawing the drug from sale.
    FDA has reviewed its records and, under Sec.  314.161, has 
determined that SODIUM FLUORIDE F 18 (sodium fluoride F-18) injection, 
10 to 200 mCi/mL, was not withdrawn from sale for reasons of safety or 
effectiveness. Accordingly, the Agency will continue to list SODIUM 
FLUORIDE F 18 (sodium fluoride F-18) injection, 10 to 200 mCi/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 SODIUM FLUORIDE F 18 
(sodium fluoride F-18) injection, 10 to 200 mCi/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: June 20, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-15815 Filed 6-23-11; 8:45 am]
BILLING CODE 4160-01-P