Determination That LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), Injectable 3.75 Milligrams/Vial and 7.5 Milligrams/Vial; and LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension), Injectable 7.5 Milligrams/Vial and 7.5 Milligrams/Vial, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 49327-49328 [2014-19713]
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<![CDATA[
Federal Register / Vol. 79, No. 161 / Wednesday, August 20, 2014 / Notices
49327
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Total ..............................................................................
1 There
Total annual
responses
Average
burden per
response
........................
........................
........................
Total hours
654
are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated number of temporary
marketing permit applications and
hours per response is an average based
on our experience with applications
received for the past 3 years and
information from firms that have
submitted recent requests for temporary
marketing permits. Based on this
information, we estimate that there will
be, on average, approximately 13 firms
submitting requests for 2 temporary
marketing permits per year over the next
3 years.
Thus, we estimate that 13 respondents
will submit 2 requests for temporary
marketing permits annually under
§ 130.17(c). The estimated number of
respondents for § 130.17(i) is minimal
because this section is seldom used by
the respondents; therefore, the Agency
estimates that there will be one or fewer
respondents annually with two or fewer
requests for extension of the marketing
permit under § 130.17(i). The estimated
number of hours per response is an
average based on the Agency’s
experience and information from firms
that have submitted recent requests for
temporary marketing permits. We
estimate that 13 respondents each will
submit 2 requests for temporary
marketing permits under § 130.17(c) and
that it will take a respondent 25 hours
per request to comply with the
requirements of that section, for a total
of 650 hours. We estimate that one
respondent will submit two requests for
extension of its temporary marketing
permits under § 130.17(i) and that it will
take a respondent 2 hours per request to
comply with the requirements of that
section, for a total of 4 hours.
Dated: August 14, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–19695 Filed 8–19–14; 8:45 am]
BILLING CODE 4164–01–P
emcdonald on DSK67QTVN1PROD with NOTICES
Number of
responses per
respondent
........................
21 CFR Section/activity
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16:44 Aug 19, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–P–1510]
Determination That LUPRON DEPOT–
PED (Leuprolide Acetate for Depot
Suspension), Injectable 3.75
Milligrams/Vial and 7.5 Milligrams/Vial;
and LUPRON DEPOT–PED (Leuprolide
Acetate for Depot Suspension),
Injectable 7.5 Milligrams/Vial and 7.5
Milligrams/Vial, Were 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 LUPRON DEPOT–PED (leuprolide
acetate for depot suspension), Injectable
3.75 milligrams (mg)/vial and 7.5 mg/
vial; and LUPRON DEPOT–PED
(leuprolide acetate for depot
suspension), Injectable 7.5 mg/vial and
7.5 mg/vial, were not withdrawn from
sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for
leuprolide acetate for depot suspension,
injectable 3.75 mg/vial and 7.5 mg/vial;
and injectable 7.5 mg/vial and 7.5 mg/
vial, if all other legal and regulatory
requirements are met. However, in
considering whether to file an ANDA for
leuprolide acetate for depot suspension,
future applicants are advised that they
may not be able to obtain LUPRON
DEPOT–PED (leuprolide acetate for
depot suspension), Injectable 3.75 mg/
vial and 7.5 mg/vial; or LUPRON
DEPOT–PED (leuprolide acetate for
depot suspension), Injectable 7.5 mg/
vial and 7.5 mg/vial, for bioequivalence
testing because the product has not been
commercially available for a number of
years. An ANDA applicant who is
unable to obtain LUPRON DEPOT–PED
(leuprolide acetate for depot
suspension), Injectable 3.75 mg/vial and
7.5 mg/vial; or LUPRON DEPOT–PED
(leuprolide acetate for depot
suspension), Injectable 7.5 mg/vial and
7.5 mg/vial, for bioequivalence testing
SUMMARY:
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
should contact the Office of Generic
Drugs for a determination of what is
necessary to show bioavailability and
the same therapeutic effect.
FOR FURTHER INFORMATION CONTACT:
Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6208, Silver Spring,
MD 20993–0002, 240–402–0979.
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 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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
E:\FR\FM\20AUN1.SGM
20AUN1
emcdonald on DSK67QTVN1PROD with NOTICES
49328
Federal Register / Vol. 79, No. 161 / Wednesday, August 20, 2014 / Notices
LUPRON DEPOT–PED (leuprolide
acetate for depot suspension), Injectable
3.75 mg/vial and 7.5 mg/vial; and
LUPRON DEPOT–PED (leuprolide
acetate for depot suspension), Injectable
7.5 mg/vial and 7.5 mg/vial, are the
subject of NDA 020263, held by Abbvie
Endocrine, Inc., and initially approved
on April 16, 1993. LUPRON DEPOT–
PED is indicated for treatment of
children with central precocious
puberty.
In a report dated January 30, 1999,
Abbvie notified FDA that LUPRON
DEPOT–PED (leuprolide acetate for
depot suspension), Injectable 3.75 mg/
vial and 7.5 mg/vial; and LUPRON
DEPOT–PED (leuprolide acetate for
depot suspension), Injectable 7.5 mg/
vial and 7.5 mg/vial, were being
discontinued, and FDA moved the drug
products to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Joan Janulis, on behalf of Lachmann
Consultant Services, Inc., submitted a
citizen petition dated November 4, 2013
(Docket No. FDA–2013–P–1510), under
21 CFR 10.30, requesting that the
Agency determine whether LUPRON
DEPOT–PED, Injectable 3.75 mg/vial
and 7.5 mg/vial; and LUPRON DEPOT–
PED, Injectable 7.5 mg/vial and 7.5 mg/
vial, were withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that LUPRON DEPOT–PED,
Injectable 3.75 mg/vial and 7.5 mg/vial;
and LUPRON DEPOT–PED, Injectable
7.5 mg/vial and 7.5 mg/vial, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that LUPRON DEPOT–PED,
Injectable 3.75 mg/vial and 7.5 mg/vial;
or LUPRON DEPOT–PED, Injectable 7.5
mg/vial and 7.5 mg/vial, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of LUPRON
DEPOT–PED, Injectable 3.75 mg/vial
and 7.5 mg/vial; and LUPRON DEPOT–
PED, Injectable 7.5 mg/vial and 7.5 mg/
vial, from sale. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that the products were not
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list LUPRON DEPOT–PED,
Injectable 3.75 mg/vial and 7.5 mg/vial;
VerDate Mar<15>2010
16:44 Aug 19, 2014
Jkt 232001
and LUPRON DEPOT–PED, Injectable
7.5 mg/vial and 7.5 mg/vial, 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 LUPRON DEPOT–PED, Injectable
3.75 mg/vial and 7.5 mg/vial; or
LUPRON DEPOT–PED, Injectable 7.5
mg/vial and 7.5 mg/vial, 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 these drug products should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
organization. Nominations will be
accepted for current vacancies and for
those that will or may occur through
December 2014.
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and therefore, encourages
nominations of appropriately qualified
candidates from these groups.
Dated: August 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and
Planning.
Any consumer organization
interested in participating in the
selection of an appropriate voting or
nonvoting member to represent
consumer interests on an FDA advisory
committee or panel may send a letter or
email stating that interest to the FDA
(see ADDRESSES) by September 19, 2014,
for vacancies listed in this notice.
Concurrently, nomination materials for
prospective candidates should be sent to
FDA (see ADDRESSES) by September 19,
2014.
[FR Doc. 2014–19713 Filed 8–19–14; 8:45 am]
ADDRESSES:
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1179]
Request for Nominations for Voting
and/or Nonvoting Consumer
Representatives on Public Advisory
Committees or Panels and Request for
Notification From Consumer
Organizations Interested in
Participating in the Selection Process
for Nominations for Voting and/or
Nonvoting Consumer Representatives
on Public Advisory Committees or
Panels
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is requesting that
any consumer organizations interested
in participating in the selection of
voting and/or nonvoting consumer
representatives to serve on its advisory
committees or panels notify FDA in
writing. FDA is also requesting
nominations for voting and/or
nonvoting consumer representatives to
serve on advisory committees and/or
panels for which vacancies currently
exist or are expected to occur in the near
future. Nominees recommended to serve
as a voting or nonvoting consumer
representative may be self-nominated or
may be nominated by a consumer
SUMMARY:
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
DATES:
All statements of interest
from consumer organizations interested
in participating in the selection process
and consumer representative
nominations should submit their
information electronically to
kimberly.hamilton@fda.hhs.gov or by
mail to Advisory Committee Oversight
and Management Staff, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002, FAX
301–847–8640.
Consumer representative nominations
should be submitted electronically by
logging into the FDA advisory
Committee Membership Nomination
Portal at https://
www.accessdata.fda.gov/scripts/
FACTRSPortal/FACTRS/index.cfm or by
mail to Advisory Committee Oversight
and Management Staff, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5103,
Silver Spring, MD 20993–0002, or by fax
to 301–847–8640. Additional
information about becoming a member
on an FDA advisory committee can also
be obtained by visiting FDA’s Web site
at https://www.fda.gov/
AdvisoryCommittees/default.htm.
FOR FURTHER GENERAL INFORMATION
CONTACT: Kimberly Hamilton, Advisory
Committee Oversight and Management
Staff, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 32,
Rm. 5117, Silver Spring, MD 20993–
0002, 301–796–6319, email:
kimberly.hamilton@fda.hhs.gov.
For
questions relating to specific advisory
committees or panels, contact the
following persons listed in table 1:
SUPPLEMENTARY INFORMATION:
E:\FR\FM\20AUN1.SGM
20AUN1
]]>Agencies
[Federal Register Volume 79, Number 161 (Wednesday, August 20, 2014)]
[Notices]
[Pages 49327-49328]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-19713]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-1510]
Determination That LUPRON DEPOT-PED (Leuprolide Acetate for Depot
Suspension), Injectable 3.75 Milligrams/Vial and 7.5 Milligrams/Vial;
and LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension),
Injectable 7.5 Milligrams/Vial and 7.5 Milligrams/Vial, Were 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
LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable
3.75 milligrams (mg)/vial and 7.5 mg/vial; and LUPRON DEPOT-PED
(leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and
7.5 mg/vial, were not withdrawn from sale for reasons of safety or
effectiveness. This determination will allow FDA to approve abbreviated
new drug applications (ANDAs) for leuprolide acetate for depot
suspension, injectable 3.75 mg/vial and 7.5 mg/vial; and injectable 7.5
mg/vial and 7.5 mg/vial, if all other legal and regulatory requirements
are met. However, in considering whether to file an ANDA for leuprolide
acetate for depot suspension, future applicants are advised that they
may not be able to obtain LUPRON DEPOT-PED (leuprolide acetate for
depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON
DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/
vial and 7.5 mg/vial, for bioequivalence testing because the product
has not been commercially available for a number of years. An ANDA
applicant who is unable to obtain LUPRON DEPOT-PED (leuprolide acetate
for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or
LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable
7.5 mg/vial and 7.5 mg/vial, for bioequivalence testing should contact
the Office of Generic Drugs for a determination of what is necessary to
show bioavailability and the same therapeutic effect.
FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-402-0979.
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 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.
[[Page 49328]]
LUPRON DEPOT-PED (leuprolide acetate for depot suspension),
Injectable 3.75 mg/vial and 7.5 mg/vial; and LUPRON DEPOT-PED
(leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and
7.5 mg/vial, are the subject of NDA 020263, held by Abbvie Endocrine,
Inc., and initially approved on April 16, 1993. LUPRON DEPOT-PED is
indicated for treatment of children with central precocious puberty.
In a report dated January 30, 1999, Abbvie notified FDA that LUPRON
DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75
mg/vial and 7.5 mg/vial; and LUPRON DEPOT-PED (leuprolide acetate for
depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, were being
discontinued, and FDA moved the drug products to the ``Discontinued
Drug Product List'' section of the Orange Book.
Joan Janulis, on behalf of Lachmann Consultant Services, Inc.,
submitted a citizen petition dated November 4, 2013 (Docket No. FDA-
2013-P-1510), under 21 CFR 10.30, requesting that the Agency determine
whether LUPRON DEPOT-PED, Injectable 3.75 mg/vial and 7.5 mg/vial; and
LUPRON DEPOT-PED, Injectable 7.5 mg/vial and 7.5 mg/vial, were
withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that LUPRON DEPOT-PED, Injectable 3.75 mg/vial and
7.5 mg/vial; and LUPRON DEPOT-PED, Injectable 7.5 mg/vial and 7.5 mg/
vial, were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
LUPRON DEPOT-PED, Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON
DEPOT-PED, Injectable 7.5 mg/vial and 7.5 mg/vial, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of LUPRON DEPOT-PED,
Injectable 3.75 mg/vial and 7.5 mg/vial; and LUPRON DEPOT-PED,
Injectable 7.5 mg/vial and 7.5 mg/vial, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have reviewed the available evidence
and determined that the products were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will continue to list LUPRON DEPOT-PED,
Injectable 3.75 mg/vial and 7.5 mg/vial; and LUPRON DEPOT-PED,
Injectable 7.5 mg/vial and 7.5 mg/vial, 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 LUPRON DEPOT-PED, Injectable 3.75
mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED, Injectable 7.5 mg/vial
and 7.5 mg/vial, 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 these drug products should be revised
to meet current standards, the Agency will advise ANDA applicants to
submit such labeling.
Dated: August 14, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
[FR Doc. 2014-19713 Filed 8-19-14; 8:45 am]
BILLING CODE 4164-01-P
