Determination That MIVACRON (Mivacurium Chloride) Injection Equivalent to 2 Milligrams Base/Milliliter Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 44558-44559 [E7-15488]
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Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Notices
sroberts on PROD1PC70 with NOTICES
Agreement to the National Alliance for
Hispanic Health (the Alliance). The
purpose of the agreement is to empower
consumers to improve their health by
providing better consumer health
information; ensure that health
information available to consumers is
clear, informative, and effective;
leverage opportunities to eliminate
health disparities in subpopulations;
respond to the health promotion and
disease prevention objectives of the
Department of Health and Human
Services (HHS) ‘‘Healthy People 2010’’
document; and improve health literacy
for Hispanic Americans. FDA
anticipates providing $ 35,000.00 (direct
and indirect costs) in fiscal year (FY)
2007 in support of this project. Subject
to the availability of funds and
successful performance, two additional
years of support up to $35,000.00 per
year (direct and indirect) will be
available.
DATES: Applications are due August 24,
2007.
FOR FURTHER INFORMATION CONTACT:
Gladys M. Bohler, Office of Acquisitions
and Grants Services, Food and Drug
Administration, 5630 Fishers Lane, rm.
2105, Rockville, MD 20857, 301–827–
7168, or e-mail: gladys.melendezbohler@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Application and Submission
Information
In FY 2007, all applications must be
received by August 24, 2007.
Applications must be received by close
of business on the established receipt
date. Late applications may be accepted
under extreme circumstances beyond
the control of the applicant. Applicants
not received on time will not be
considered for review and will generally
be returned to the applicant.
Applications must be submitted
electronically through grants.gov. The
application must be on SF424 R&R
(Research and Related Portable
Document Format). Exceptions may be
made in unusual circumstances and on
a case by case basis. Applicants must
download the SF424 (R&R) application
forms and 424 (R&R) Application Guide
for this funding opportunity through
grants.gov at https://www.grants.gov/
Apply. Please note, only the forms
package directly attached to this specific
funding opportunity in grants.gov can
be used.
If electronic submission is impossible,
please contact Gladys M. Bohler, Grants
Management Specialist, at 301–827–
7168 or by e-mail at gladys.melendezbohler@fda.hhs.gov (See Agency
Contacts). When submitting
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19:14 Aug 07, 2007
Jkt 211001
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This database is a government-wide
warehouse of commercial and financial
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conducting business with the Federal
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Registration with CCR is a
requirement and is consistent with the
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create a citizen-centered Web presence
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face to industry.’’ The preferred method
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well as steps to walk you through the
registration process.
In order to access grants.gov, an
applicant will be required to register
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Information about this is available at
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(FDA has verified the Web site address,
but we are not responsible for
subsequent changes to the Web site after
this document publishes in the Federal
Register.)
II. Agency Contacts
For issues regarding the
administrative and financial
management aspects of this notice,
contact: Gladys M. Bohler by mail:
Office of Acquisitions and Grants
Services, Food and Drug
Administration, 5630 Fishers Lane,
Rockville, MD 20857; telephone: 301–
827–7168; FAX: 301–827–7101; e-mail:
gladys.melendez-bohler@fda.gov.
For issues regarding the programmatic
aspects, contact: Mary C. Hitch, Senior
Policy Advisor, Office of External
Relations (HF–10), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857; telephone: 301–
827–4406; FAX: 301–827–8030; e-mail:
mary.hitch@fda.hhs.gov.
Dated: August 2, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7–15491 Filed 8–7–07; 8:45 am]
BILLING CODE 4160–01–S
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0445]
Determination That MIVACRON
(Mivacurium Chloride) Injection
Equivalent to 2 Milligrams Base/
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 MIVACRON (mivacurium chloride)
injection equivalent to (EQ) 2
milligrams (mg) base/milliliter (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 mivacurium
chloride injection EQ 2 mg base/mL.
FOR FURTHER INFORMATION CONTACT:
Christine F. Rogers, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–594–
2041.
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
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 (the 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 removed from the list if the
agency withdraws or suspends approval
SUPPLEMENTARY INFORMATION:
E:\FR\FM\08AUN1.SGM
08AUN1
sroberts on PROD1PC70 with NOTICES
Federal Register / Vol. 72, No. 152 / Wednesday, August 8, 2007 / Notices
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 § 314.161(a)(1) (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.
MIVACRON (mivacurium chloride)
injection EQ 2 mg base/mL is the subject
of approved NDA 20–098 held by
Abbott Laboratories, Inc. (Abbott).
MIVACRON is a short-acting
neuromuscular blocking agent indicated
for inpatients and outpatients, as an
adjunct to general anesthesia, to
facilitate tracheal intubation and to
provide skeletal muscle relaxation
during surgery or mechanical
ventilation. FDA approved the NDA for
MIVACRON on January 22, 1992.
Abbott ceased marketing MIVACRON in
July 2006.
Regulus Pharmaceutical Consulting,
Inc., submitted a citizen petition dated
October 25, 2006 (Docket No. 2006P–
0445/CP1), under 21 CFR 10.30,
requesting that the agency determine, as
described in § 314.161, whether
MIVACRON (mivacurium chloride)
injection EQ 2 mg base/mL was
withdrawn from sale for reasons of
safety or effectiveness. The petitioner
has identified no data or other
information suggesting that MIVACRON
was withdrawn from sale as a result of
safety or effectiveness concerns.
We have reviewed our records and
determined that Abbott’s MIVACRON
(mivacurium chloride) injection EQ 2
mg base/mL was not withdrawn from
sale for reasons of safety or
effectiveness. We have also
independently evaluated relevant
literature and data for adverse event
reports and have determined that this
product was not withdrawn for reasons
of safety or effectiveness.
After considering the citizen petition
and reviewing its records, FDA has
determined that, for the reasons
outlined in this notice, Abbott’s
MIVACRON (mivacurium chloride)
injection EQ 2 mg base/mL was not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
agency will list MIVACRON
(mivacurium chloride) injection EQ 2
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
VerDate Aug<31>2005
19:14 Aug 07, 2007
Jkt 211001
discontinued from marketing for reasons
other than safety or effectiveness.
ANDAs that refer to MIVACRON
(mivacurium chloride) injection EQ 2
mg base/mL 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 labeling for this drug
product should be revised to meet
current standards, the agency will
advise ANDA applicants to submit such
labeling.
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7–15488 Filed 8–7–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P–0520]
Determination That Methotrexate
Injection, USP, Preservative Free,
Equivalent to 500 Milligrams Base/20
Milliliters (25 Milligrams/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 methotrexate injection, USP,
preservative free, equivalent to (Eq.) 500
milligrams (mg) base/20 milliliters (mL)
(25 mg/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
methotrexate injection, preservative
free, Eq. 500 mg base/20 mL (25 mg/
mL).
FOR FURTHER INFORMATION CONTACT:
Elena Cohen, Center for Drug Evaluation
and Research (HFD–7), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–594–2041.
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
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
PO 00000
Frm 00077
Fmt 4703
Sfmt 4703
44559
the ‘‘listed drug,’’ which is typically 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 generally known 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).
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.
Methotrexate injection, USP,
preservative free, Eq. 500 mg base/20
mL (25 mg/mL), is the subject of
approved NDA 11–719 currently held
by Mayne Pharma USA (Mayne).
Although NDA 11–719 was originally
approved in 1959, this formulation and
dosage was approved in April 2005 (S–
108). Methotrexate is an antifolate
cytotoxic drug used in the treatment of
a variety of malignancies, including
acute lymphoblastic leukemia,
osteosarcoma, advanced metastatic
breast cancer, and others. It is also used
to treat some inflammatory conditions
such as rheumatoid arthritis. To date,
Mayne has not marketed methotrexate
injection, USP, preservative free, Eq.
500 mg base/20 mL (25 mg/mL). At the
request of the sponsor, the product was
moved to the discontinued section of
the Orange Book in June 2005. In
previous instances (see, e.g., the Federal
Register document of December 30,
2002 (67 FR 79640), addressing a
relisting request for Diazepam
Autoinjector), 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.
SICOR Pharmaceuticals, Inc.,
submitted a citizen petition dated
E:\FR\FM\08AUN1.SGM
08AUN1
]]>Agencies
[Federal Register Volume 72, Number 152 (Wednesday, August 8, 2007)]
[Notices]
[Pages 44558-44559]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15488]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006P-0445]
Determination That MIVACRON (Mivacurium Chloride) Injection
Equivalent to 2 Milligrams Base/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
MIVACRON (mivacurium chloride) injection equivalent to (EQ) 2
milligrams (mg) base/milliliter (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 mivacurium
chloride injection EQ 2 mg base/mL.
FOR FURTHER INFORMATION CONTACT: Christine F. Rogers, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-594-2041.
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
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 (the 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 removed from the list
if the agency withdraws or suspends approval
[[Page 44559]]
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 Sec. 314.161(a)(1) (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.
MIVACRON (mivacurium chloride) injection EQ 2 mg base/mL is the
subject of approved NDA 20-098 held by Abbott Laboratories, Inc.
(Abbott). MIVACRON is a short-acting neuromuscular blocking agent
indicated for inpatients and outpatients, as an adjunct to general
anesthesia, to facilitate tracheal intubation and to provide skeletal
muscle relaxation during surgery or mechanical ventilation. FDA
approved the NDA for MIVACRON on January 22, 1992. Abbott ceased
marketing MIVACRON in July 2006.
Regulus Pharmaceutical Consulting, Inc., submitted a citizen
petition dated October 25, 2006 (Docket No. 2006P-0445/CP1), under 21
CFR 10.30, requesting that the agency determine, as described in Sec.
314.161, whether MIVACRON (mivacurium chloride) injection EQ 2 mg base/
mL was withdrawn from sale for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
MIVACRON was withdrawn from sale as a result of safety or effectiveness
concerns.
We have reviewed our records and determined that Abbott's MIVACRON
(mivacurium chloride) injection EQ 2 mg base/mL was not withdrawn from
sale for reasons of safety or effectiveness. We have also independently
evaluated relevant literature and data for adverse event reports and
have determined that this product was not withdrawn for reasons of
safety or effectiveness.
After considering the citizen petition and reviewing its records,
FDA has determined that, for the reasons outlined in this notice,
Abbott's MIVACRON (mivacurium chloride) injection EQ 2 mg base/mL was
not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will list MIVACRON (mivacurium chloride)
injection EQ 2 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 MIVACRON (mivacurium chloride)
injection EQ 2 mg base/mL 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 labeling for this drug product should be
revised to meet current standards, the agency will advise ANDA
applicants to submit such labeling.
Dated: July 30, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-15488 Filed 8-7-07; 8:45 am]
BILLING CODE 4160-01-S
