Determination That ZOMETA (Zoledronic Acid for Injection), Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for Injection, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 17196-17197 [E9-8524]
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Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices
address one or more of the following
points: (1) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the function of the agency, including
whether the information will have
practical utility; (2) Evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and (4) Minimize the burden
of the collection of information on those
who are to respond, including the use
of appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Joseph T. Hughes,
Jr., Director, Worker Education and
Training Branch, Division of Extramural
Research and Training, NIEHS, P.O. Box
12233, Research Triangle Park, NC
27709 or call non-toll-free number (919)
541–0217 or E-mail your request,
including your address to
wetp@niehs.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60-days of the date of
this publication.
Dated: April 2, 2009.
Marc S. Hollander,
NIEHS Associate Director for Management.
[FR Doc. E9–8472 Filed 4–13–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–P–0250] (formerly
Docket No. 2007P–0341)
Determination That ZOMETA
(Zoledronic Acid for Injection),
Equivalent to 4 Milligrams Base Per
Vial, Lyophilized Powder for Injection,
Was Not Withdrawn From Sale for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 ZOMETA (zoledronic acid for
injection), equivalent to (EQ) 4
milligrams (mg) base/vial, lyophilized
VerDate Nov<24>2008
16:39 Apr 13, 2009
Jkt 217001
powder for injection, was not
withdrawn from sale for reasons of
safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for zoledronic
acid lyophilized powder for injection, 4mg base/vial.
FOR FURTHER INFORMATION CONTACT:
Nancy Boocker, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
sponsors 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. Sponsors of
ANDAs 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 generally known as the
‘‘Orange Book.’’ Under FDA regulations,
drugs are withdrawn 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).
Under 21 CFR 314.161(a)(1), the
agency must determine whether a listed
drug was withdrawn from sale for
reasons of safety or effectiveness before
an ANDA that refers to that listed drug
may be approved. FDA may not approve
an ANDA that does not refer to a listed
drug.
ZOMETA (zoledronic acid for
injection), EQ 4-mg base/vial,
lyophilized powder for injection, is the
subject of approved NDA 21–223 held
by Novartis Pharmaceuticals Corp.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
(Novartis). Zoledronic acid, lyophilized
powder for injection, EQ 4-mg base/vial,
is indicated for treatment of
hypercalcemia of malignancy. It also is
indicated for the treatment of patients
with multiple myeloma and patients
with documented bone metastases from
solid tumors, in conjunction with
standard antineoplastic therapy.
Novartis ceased manufacturing
ZOMETA (zoledronic acid for injection),
EQ 4 mg-base/vial, lyophilized powder
for injection, in May 2003. On
September 13, 2007, Kendle
International, on behalf of Sun
Pharmaceutical Industries Ltd.,
submitted a citizen petition (Docket No.
2007P–0341/CP1), under 21 CFR 10.30,
requesting that the agency determine
whether zoledronic acid lyophilized
powder for injection, EQ 4-mg base/vial,
was withdrawn from sale for reasons of
safety or effectiveness.
The agency has determined that
ZOMETA (zoledronic acid for injection),
EQ 4-mg base/vial, lyophilized powder
for injection, was not withdrawn from
sale for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that zoledronic acid
lyophilized powder for injection, 4-mg
base/vial, was withdrawn from sale as a
result of safety or effectiveness
concerns. FDA’s independent
evaluation of relevant information has
uncovered no information that would
indicate this product was withdrawn for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing agency records, FDA
determines that for the reasons outlined
previously, ZOMETA (zoledronic acid
for injection), EQ 4-mg base/vial,
lyophilized powder for injection, was
not withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will continue to list ZOMETA
(zoledronic acid for injection), 4-mg
base/vial, lyophilized powder for
injection, 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 ZOMETA
(zoledronic acid for injection), EQ 4-mg
base/vial, lyophilized powder for
injection, may be approved by the
agency as long as they meet all relevant
legal and regulatory requirements for
the approval of ANDAs. If FDA
determines that the labeling of this drug
product should be revised to meet
current standards, the agency will
advise ANDA applicants to submit such
labeling.
E:\FR\FM\14APN1.SGM
14APN1
Federal Register / Vol. 74, No. 70 / Tuesday, April 14, 2009 / Notices
Dated: March 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–8524 Filed 4–13–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Government-Owned Inventions;
Availability for Licensing
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
SUMMARY: The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
35 U.S.C. 207 to achieve expeditious
commercialization of results of
Federally-funded research and
development. Foreign patent
applications are filed on selected
inventions to extend market coverage
for companies and may also be available
for licensing.
ADDRESSES: Licensing information and
copies of the U.S. patent applications
listed below may be obtained by writing
to the indicated licensing contact at the
Office of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301/
496–7057; fax: 301/402–0220. A signed
Confidential Disclosure Agreement will
be required to receive copies of the
patent applications.
Insect Salivary Proteins as Potent
Adjuvants for Enhancing Immune
Responses
Description of Technology: This
invention relates to the discovery that
specific sand fly salivary proteins have
marked effects on the outcome of
Leishmania infection. These proteins
have the ability to stimulate strong Th1
and Th2 responses. The Th1 responses
with one protein, PpSP15, result in
immune protection while the Th2
responses to another protein, PpSP44,
exacerbate infection. The protective
protein enhanced a specific immune
response to the infection, suggesting
that it acts as an adjuvant to alter the
environment and presentation of the
parasite antigens.
These immunogenic salivary proteins,
capable of driving Th1 or Th2
responses, can be used as adjuvants in
vaccine development for a broad
spectrum of diseases that require
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16:39 Apr 13, 2009
Jkt 217001
different immune responses. They may
therefore be used to enhance immune
responses to pathogens other than
Leishmania parasites. They are also very
potent in their effect, and small doses
are sufficient to elicit a strong immune
response. This potency can reduce the
need to use chemical adjuvants, which
often require large mounts of material
and can have deleterious side effects.
Applications:
• Vaccine for Leishmania parasite
and other pathogenic infections.
• Potent adjuvant for a broad
spectrum of diseases.
Advantages: Efficient, potent, and less
toxic than many chemical adjuvants.
Development Status: Early Stage.
Market:
• 88 countries with an estimated 2
million people affected each year.
• Estimated 350 million at risk
worldwide.
Inventors: Jesus G. Valenzuela et al.
(NIAID).
Publication: F Oliveira, PG Lawyer, S
Kamhawi, JG Valenzuela. Immunity to
distinct sand fly salivary proteins
primes the anti-Leishmania immune
response towards protection or
exacerbation of disease. PLoS Negl Trop
Dis. 2008 Apr 16;2(4):e226.
Patent Status: U.S. Provisional
Application No. 61/089,884 filed 08
Aug 2008 (HHS Reference No. E–303–
2008/0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Jeffrey A. James
PhD; 301–435–5474;
jeffreyja@mail.nih.gov.
Collaborative Research Opportunity:
The NIAID, Office of Technology
Development is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize the Insect Salivary
Proteins as potent immune response
adjuvants. Please contact Charles
Rainwater at crainwater@niaid.nih.gov
or 301/496–2644 for more information.
Anti-Cancer Oligodeoxynucleotides
Description of Technology: A majority
of human cancers originate from
epithelial tissue. A common cancer of
epithelial cell origin is non-melanoma
skin cancer (NMSC), including basal
cell carcinoma (BCC) and squamous cell
carcinoma (SCC), with more than seven
hundred thousand (700,000) new cases
diagnosed each year in the United States
alone. BCC is rarely life-threatening
because it is slow growing and is mostly
localized. Unlike BCC, SCC metastasizes
at a rate of two (2) to six (6) percent over
several years after the initial diagnosis.
A highly malignant form invades and
PO 00000
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17197
destroys tissue, and then metastasizes,
initially to a regional lymph node before
more distant organs such as the lungs or
brain are affected. SCC is commonly
encountered in a number of epithelial
tissues, including the oral cavity,
esophagus, larynx, bronchi, intestines,
colon, genital tract, and skin.
This application relates to
suppressive CpG oligodeoxynucleotides
(ODNs). This application claims
suppressive ODN compositions and
their use to prevent or delay the
formation of a tumor, reducing the risk
of developing a tumor, treating a tumor,
preventing conversion of a benign to a
malignant lesion, or preventing
metastasis. Topical application of the
ODNs of this invention in preclinical
studies resulted in significantly fewer
animals developing papillomas and
fewer papillomas/animal. The invention
also relates to use of suppressive ODNs
to prevent/delay cancer when
administered systemically as well as
locally.
Application: Development of anticancer vaccines, therapeutics and
diagnostics.
Development Status: ODNs have been
synthesized and preclinical studies have
been performed.
Inventors: Dennis M. Klinman and
Hidekazu Ikeuchi (NCI)
Patent Status: U.S. Provisional
Application No. 61/119,998 filed 04 Dec
2008 (HHS Reference No. E–296–2008/
0–US–01).
Licensing Status: Available for
licensing.
Licensing Contact: Peter A. Soukas,
J.D.; 301–435–4646;
soukasp@mail.nih.gov.
Collaborative Research Opportunity:
The National Cancer Institute,
Laboratory of Experimental
Immunology, is seeking statements of
capability or interest from parties
interested in collaborative research to
further develop, evaluate, or
commercialize this technology. Please
contact John D. Hewes, PhD at 301–435–
3121 or hewesj@mail.nih.gov for more
information.
Neutralization of Hepatitis C Virus
(HCV)
Description of Technology: Available
for licensing and commercial
development are compositions and
methods for preventing and/or treating
infection caused by hepatitis C virus
(HCV). The invention is based on
mapping studies conducted by the
inventors of two epitopes within HCV
E2: epitope I and epitope II. It has been
discovered that epitope I is involved in
virus neutralization but that epitope II
mediates antibody interference,
E:\FR\FM\14APN1.SGM
14APN1
]]>Agencies
[Federal Register Volume 74, Number 70 (Tuesday, April 14, 2009)]
[Notices]
[Pages 17196-17197]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8524]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-P-0250] (formerly Docket No. 2007P-0341)
Determination That ZOMETA (Zoledronic Acid for Injection),
Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder for
Injection, 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
ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams
(mg) base/vial, lyophilized powder for injection, was not withdrawn
from sale for reasons of safety or effectiveness. This determination
will allow FDA to approve abbreviated new drug applications (ANDAs) for
zoledronic acid lyophilized powder for injection, 4-mg base/vial.
FOR FURTHER INFORMATION CONTACT: Nancy Boocker, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products approved under an ANDA procedure. ANDA
sponsors 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. Sponsors of ANDAs 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 generally known as the ``Orange
Book.'' Under FDA regulations, drugs are withdrawn 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).
Under 21 CFR 314.161(a)(1), the agency must determine whether a
listed drug was withdrawn from sale for reasons of safety or
effectiveness before an ANDA that refers to that listed drug may be
approved. FDA may not approve an ANDA that does not refer to a listed
drug.
ZOMETA (zoledronic acid for injection), EQ 4-mg base/vial,
lyophilized powder for injection, is the subject of approved NDA 21-223
held by Novartis Pharmaceuticals Corp. (Novartis). Zoledronic acid,
lyophilized powder for injection, EQ 4-mg base/vial, is indicated for
treatment of hypercalcemia of malignancy. It also is indicated for the
treatment of patients with multiple myeloma and patients with
documented bone metastases from solid tumors, in conjunction with
standard antineoplastic therapy. Novartis ceased manufacturing ZOMETA
(zoledronic acid for injection), EQ 4 mg-base/vial, lyophilized powder
for injection, in May 2003. On September 13, 2007, Kendle
International, on behalf of Sun Pharmaceutical Industries Ltd.,
submitted a citizen petition (Docket No. 2007P-0341/CP1), under 21 CFR
10.30, requesting that the agency determine whether zoledronic acid
lyophilized powder for injection, EQ 4-mg base/vial, was withdrawn from
sale for reasons of safety or effectiveness.
The agency has determined that ZOMETA (zoledronic acid for
injection), EQ 4-mg base/vial, lyophilized powder for injection, was
not withdrawn from sale for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
zoledronic acid lyophilized powder for injection, 4-mg base/vial, was
withdrawn from sale as a result of safety or effectiveness concerns.
FDA's independent evaluation of relevant information has uncovered no
information that would indicate this product was withdrawn for reasons
of safety or effectiveness.
After considering the citizen petition and reviewing agency
records, FDA determines that for the reasons outlined previously,
ZOMETA (zoledronic acid for injection), EQ 4-mg base/vial, lyophilized
powder for injection, was not withdrawn from sale for reasons of safety
or effectiveness. Accordingly, the agency will continue to list ZOMETA
(zoledronic acid for injection), 4-mg base/vial, lyophilized powder for
injection, 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
ZOMETA (zoledronic acid for injection), EQ 4-mg base/vial, lyophilized
powder for injection, may be approved by the agency as long as they
meet all relevant legal and regulatory requirements for the approval of
ANDAs. If FDA determines that the labeling of this drug product should
be revised to meet current standards, the agency will advise ANDA
applicants to submit such labeling.
[[Page 17197]]
Dated: March 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8524 Filed 4-13-09; 8:45 am]
BILLING CODE 4160-01-S
