Determination That SODIUM FLUORIDE F 18 (Sodium Fluoride F-18) Injection, 10 to 200 Millicuries per Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 37129 [2011-15815]
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Federal Register / Vol. 76, No. 122 / Friday, June 24, 2011 / Notices
applicant for extension acted with due
diligence during the regulatory review
period by December 21, 2011. To meet
its burden, the petition must contain
sufficient facts to merit an FDA
investigation. (See H. Rept. 857, part 1,
98th Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments and written petitions. It is
only necessary to send one set of
comments. It is no longer necessary to
send three copies of mailed comments.
However, if you submit a written
petition, you must submit three copies
of the petition. Identify comments with
the docket number found in brackets in
the heading of this document.
Comments and petitions that have not
been made publicly available on
https://www.regulations.gov may be
viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: June 2, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug
Evaluation and Research.
[FR Doc. 2011–15905 Filed 6–23–11; 8:45 am]
BILLING CODE 4160–01–P
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Milliliter, Was Not Withdrawn From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.
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not withdrawn from sale for reasons of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
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
19:06 Jun 23, 2011
Jkt 223001
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 (§ 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
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
37129
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
§§ 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 § 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0012]
International Conference on
Harmonisation; Guidance on Q4B
Evaluation and Recommendation of
Pharmacopoeial Texts for Use in the
International Conference on
Harmonisation Regions; Annex 7(R2)
on Dissolution Test General Chapter;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
SUMMARY:
E:\FR\FM\24JNN1.SGM
24JNN1
]]>Agencies
[Federal Register Volume 76, Number 122 (Friday, June 24, 2011)]
[Notices]
[Page 37129]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-15815]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
