Determination That GLUCAGON (Glucagon Hydrochloride) for Injection, Equivalent to 1 Milligram Base/Vial and Equivalent to 10 Milligram Base/Vial, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 54294-54295 [2015-22673]
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54294
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Psychopharmacologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
Lhorne on DSK5TPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee:
Psychopharmacologic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on December 1, 2015, from 8 a.m.
to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
Contact Person: Kalyani Bhatt, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
PDAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: The committee will discuss
the efficacy and safety data for new drug
application (NDA) 21164, gepirone
hydrochloride extended-release tablets,
submitted by Fabre-Kramer
VerDate Sep<11>2014
14:19 Sep 08, 2015
Jkt 235001
Pharmaceuticals, Inc., for the proposed
indication of major depressive disorder.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before November 23, 2015.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before
November 13, 2015. Time allotted for
each presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by November 16, 2015.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Kalyani Bhatt
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
PO 00000
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: September 2, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2015–22593 Filed 9–8–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–P–0248]
Determination That GLUCAGON
(Glucagon Hydrochloride) for Injection,
Equivalent to 1 Milligram Base/Vial and
Equivalent to 10 Milligram Base/Vial,
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 GLUCAGON (glucagon
hydrochloride) for injection, equivalent
to (EQ) 1 milligram (mg) base/vial and
EQ 10 mg base/vial, was not withdrawn
from sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for glucagon
hydrochloride for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, if all
other legal and regulatory requirements
are met.
FOR FURTHER INFORMATION CONTACT:
Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6206, Silver Spring,
MD 20993, 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).
SUMMARY:
E:\FR\FM\09SEN1.SGM
09SEN1
Lhorne on DSK5TPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 174 / Wednesday, September 9, 2015 / Notices
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.
GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, is the
subject of NDA 12–122 held by Eli Lilly,
and initially approved onNovember 14,
1960. GLUCAGON is indicated for
treatment of severe hypoglycemia and as
a diagnostic aid in the radiologic
examination of the stomach, duodenum,
small bowel, and colon.
Under NDA 12–122, GLUCAGON
(glucagon hydrochloride) for injection,
EQ 1 mg base/vial and EQ 10 mg base/
vial, was produced from animal sources.
On September 11, 1998, FDA approved
Eli Lilly’s NDA 20–928 for GLUCAGON
(glucagon rDNA origin), 1mg/vial.
Subsequently, Eli Lilly discontinued
sales of animal-sourced GLUCAGON in
2002. In 2005, FDA moved animalsourced GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Walter G. Jump, on behalf of
Cornerstone Regulatory, submitted a
citizen petition dated August 7, 2007
(Docket No. FDA–2007–P–0248), under
21 CFR 10.30, requesting that the
Agency determine whether animalsourced GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, was
withdrawn from sale for reasons of
safety or effectiveness.
After considering the citizen petition,
reviewing Agency records, and based on
the information we have at this time,
FDA has determined under § 314.161
VerDate Sep<11>2014
14:19 Sep 08, 2015
Jkt 235001
that GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, was
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, was
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal from sale of
GLUCAGON (glucagon hydrochloride)
for injection, EQ 1 mg base/vial and EQ
10 mg base/vial. We have also
independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that the product was not
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/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 GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, may
be approved by the Agency as long as
they meet all other legal and regulatory
requirements for the approval of
ANDAs. However, it is the Agency’s
view that it would be challenging for a
prospective applicant to provide
adequate data to meet the statutory
requirements for an ANDA that relies on
NDA 12–122 for GLUCAGON (glucagon
hydrochloride) for injection in the
absence of comparative data with the
animal-sourced glucagon approved in
NDA 12–122.
Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–22673 Filed 9–8–15; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
54295
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–1039]
Nonclinical Evaluation of EndocrineRelated Drug Toxicity; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a
guidance for industry entitled
‘‘Nonclinical Evaluation of EndocrineRelated Drug Toxicity.’’ The purpose of
this guidance is to clarify when
additional studies are warranted after
the standard toxicology tests have been
conducted and there is a signal for
potential adverse endocrine-related
toxicity. This guidance finalizes the
draft guidance entitled ‘‘Endocrine
Disruption Potential of Drugs:
Nonclinical Evaluation’’ issued on
September 20, 2013.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Abby Jacobs, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg., 22, Rm. 6474, Silver Spring,
MD 20993–0002, 301–796–0174.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Nonclinical Evaluation of EndocrineRelated Drug Toxicity.’’ This guidance
focuses on nonclinical testing designed
to assess the potential for a drug to
cause endocrine effects that are
Frm 00037
Fmt 4703
Sfmt 4703
E:\FR\FM\09SEN1.SGM
09SEN1
]]>Agencies
[Federal Register Volume 80, Number 174 (Wednesday, September 9, 2015)]
[Notices]
[Pages 54294-54295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-22673]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-P-0248]
Determination That GLUCAGON (Glucagon Hydrochloride) for
Injection, Equivalent to 1 Milligram Base/Vial and Equivalent to 10
Milligram Base/Vial, 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
GLUCAGON (glucagon hydrochloride) for injection, equivalent to (EQ) 1
milligram (mg) base/vial and EQ 10 mg base/vial, was not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
glucagon hydrochloride for injection, EQ 1 mg base/vial and EQ 10 mg
base/vial, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6206, Silver Spring, MD 20993, 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).
[[Page 54295]]
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.
GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial
and EQ 10 mg base/vial, is the subject of NDA 12-122 held by Eli Lilly,
and initially approved onNovember 14, 1960. GLUCAGON is indicated for
treatment of severe hypoglycemia and as a diagnostic aid in the
radiologic examination of the stomach, duodenum, small bowel, and
colon.
Under NDA 12-122, GLUCAGON (glucagon hydrochloride) for injection,
EQ 1 mg base/vial and EQ 10 mg base/vial, was produced from animal
sources. On September 11, 1998, FDA approved Eli Lilly's NDA 20-928 for
GLUCAGON (glucagon rDNA origin), 1mg/vial. Subsequently, Eli Lilly
discontinued sales of animal-sourced GLUCAGON in 2002. In 2005, FDA
moved animal-sourced GLUCAGON (glucagon hydrochloride) for injection,
EQ 1 mg base/vial and EQ 10 mg base/vial, to the ``Discontinued Drug
Product List'' section of the Orange Book.
Walter G. Jump, on behalf of Cornerstone Regulatory, submitted a
citizen petition dated August 7, 2007 (Docket No. FDA-2007-P-0248),
under 21 CFR 10.30, requesting that the Agency determine whether
animal-sourced GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg
base/vial and EQ 10 mg base/vial, was withdrawn from sale for reasons
of safety or effectiveness.
After considering the citizen petition, reviewing Agency records,
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that GLUCAGON (glucagon hydrochloride) for
injection, EQ 1 mg base/vial and EQ 10 mg base/vial, was not withdrawn
for reasons of safety or effectiveness. The petitioner has identified
no data or other information suggesting that GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/vial,
was withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal from sale of
GLUCAGON (glucagon hydrochloride) for injection, EQ 1 mg base/vial and
EQ 10 mg base/vial. We have also independently evaluated relevant
literature and data for possible postmarketing adverse events. We have
reviewed the available evidence and determined that the product was not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list GLUCAGON (glucagon
hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg base/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 GLUCAGON
(glucagon hydrochloride) for injection, EQ 1 mg base/vial and EQ 10 mg
base/vial, may be approved by the Agency as long as they meet all other
legal and regulatory requirements for the approval of ANDAs. However,
it is the Agency's view that it would be challenging for a prospective
applicant to provide adequate data to meet the statutory requirements
for an ANDA that relies on NDA 12-122 for GLUCAGON (glucagon
hydrochloride) for injection in the absence of comparative data with
the animal-sourced glucagon approved in NDA 12-122.
Dated: September 2, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-22673 Filed 9-8-15; 8:45 am]
BILLING CODE 4164-01-P
