Determination That GLUCOPHAGE (Metformin Hydrochloride) Oral Tablets, 500 Milligrams, 850 Milligrams, and 1 Gram, and GLUCOPHAGE XR (Metformin Hydrochloride) Oral Extended-Release Tablets, 500 Milligrams and 750 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 72366-72367 [2019-28270]
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72366
Federal Register / Vol. 84, No. 250 / Tuesday, December 31, 2019 / Notices
• What types of regulatory trends or
information should be analyzed to
benefit the regulatory process?
• What technologies or policies could
assist with sharing of data or
interoperability of regulatory
management systems across the Federal
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providers to use regulatory information
alone or in combination with other data
to deliver commercial services or
analysis?
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assist with increasing public access to
data for or through commercial
applications?
khammond on DSKJM1Z7X2PROD with NOTICES
In-Person Attendance
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the public meetings to be held at GSA
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due to seating limitations. Pre-register
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com. Check for additional information
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Sequence No. 35 as dates approach.
Questions may be directed to
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Further details on the virtual meeting
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Meeting Accommodations
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Sign language interpretation and
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meetings and online. Any specific
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VerDate Sep<11>2014
17:30 Dec 30, 2019
Jkt 250001
auxiliary aids must be directed to
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meetings.
Panel Presentations
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Dated: December 24, 2019.
Tobias Q. Schroeder,
Director, eRulemaking Program Management
Office, Office of Regulation Management,
Office of Government-wide Policy, General
Services Administration.
[FR Doc. 2019–28242 Filed 12–30–19; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–P–3877]
Determination That GLUCOPHAGE
(Metformin Hydrochloride) Oral
Tablets, 500 Milligrams, 850 Milligrams,
and 1 Gram, and GLUCOPHAGE XR
(Metformin Hydrochloride) Oral
Extended-Release Tablets, 500
Milligrams and 750 Milligrams, 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, Agency, or we)
SUMMARY:
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
has determined that, GLUCOPHAGE
(metformin hydrochloride) oral tablets,
500 milligrams (mg), 850 mg, and 1
gram (g), and GLUCOPHAGE XR
(metformin hydrochloride) oral
extended-release tablets, 500 mg and
750 mg, were not withdrawn from sale
for reasons of safety or effectiveness.
This determination means that FDA will
not begin procedures to withdraw
approval of abbreviated new drug
applications (ANDAs) that refer to these
drug products, and it will allow FDA to
continue to approve ANDAs that refer to
these products as long as they meet
relevant legal and regulatory
requirements.
FOR FURTHER INFORMATION CONTACT:
Carlarease Hunter, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213,
Silver Spring, MD 20993–0002, 301–
796–3702, Carlarease.Hunter@
fda.hhs.gov.
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
E:\FR\FM\31DEN1.SGM
31DEN1
72367
Federal Register / Vol. 84, No. 250 / Tuesday, December 31, 2019 / Notices
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.
GLUCOPHAGE (metformin
hydrochloride) oral tablets, 500 mg, 850
mg, and 1 g, are the subject of NDA
020357, held by EMD Serono Inc. and
initially approved on March 3, 1995.
GLUCOPHAGE is indicated as an
adjunct to diet and exercise to improve
glycemic control in adults and pediatric
patients 10 years of age and older with
type 2 diabetes mellitus. GLUCOPHAGE
(metformin hydrochloride) oral tablets,
500 mg, 850 mg, and 1 g, are currently
listed in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
GLUCOPHAGE XR (metformin
hydrochloride) oral extended-release
tablets, 500 mg and 750 mg, are the
subject of NDA 021202, held by EMD
Serono Inc. and initially approved on
October 13, 2000. GLUCOPHAGE XR is
indicated as an adjunct to diet and
exercise to improve glycemic control in
adults with type 2 diabetes mellitus.
GLUCOPHAGE XR (metformin
hydrochloride) oral extended-release
tablets, 500 mg and 750 mg, are
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Harman Finochem Ltd. submitted a
citizen petition dated August 17, 2019
(Docket No. FDA–2019–P–3877), under
21 CFR 10.30, requesting that FDA
confirm that GLUCOPHAGE (metformin
hydrochloride) oral tablets were not
withdrawn from sale for reasons of
safety or effectiveness. Although the
citizen petition did not address the
GLUCOPHAGE XR (metformin
hydrochloride) oral extended-release
tablets, 500 mg and 750 mg, those
products have also been discontinued.
On our own initiative, we have also
determined whether those products
were withdrawn for safety or
effectiveness reasons.
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 GLUCOPHAGE
(metformin hydrochloride) oral tablets,
500 mg, 850 mg, and 1 g, and
GLUCOPHAGE XR (metformin
hydrochloride) oral extended-release
tablets, 500 mg and 750 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that GLUCOPHAGE
(metformin hydrochloride) oral tablets
were withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
GLUCOPHAGE (metformin
hydrochloride) oral tablets, 500 mg, 850
mg, and 1 g, and GLUCOPHAGE XR
(metformin hydrochloride) oral
extended-release tablets, 500 mg and
750 mg, 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 these drug products
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list GLUCOPHAGE
(metformin hydrochloride) oral tablets,
500 mg, 850 mg, and 1 g, and
GLUCOPHAGE XR (metformin
hydrochloride) oral extended-release
tablets, 500 mg and 750 mg, 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. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to these
drug products. Additional ANDAs for
these drug products may also 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: December 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–28270 Filed 12–30–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2013–N–0134; FDA–
2011–N–0902; FDA–2013–N–0662; FDA–
2013–N–0242; FDA–2019–N–1517; FDA–
2019–N–0549; FDA–2019–N–0305; FDA–
2012–N–0477; FDA–2016–D–2565, and FDA–
2018–N–4839]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approvals
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is publishing a
list of information collections that have
been approved by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUMMARY:
The
following is a list of FDA information
collections recently approved by OMB
under section 3507 of the Paperwork
Reduction Act of 1995 (44 U.S.C. 3507).
The OMB control number and
expiration date of OMB approval for
each information collection are shown
in table 1. Copies of the supporting
statements for the information
collections are available on the internet
at https://www.reginfo.gov/public/do/
PRAMain. An Agency may not conduct
or sponsor, and a person is not required
to respond to, a collection of
information unless it displays a
currently valid OMB control number.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
TABLE 1—LIST OF INFORMATION COLLECTIONS APPROVED BY OMB
OMB control
No.
Title of collection
Mammography Quality Standards Act Requirements .............................................................................................
Prescription Drug Product Labeling; Medication Guide Requirements ...................................................................
Applications for FDA Approval to Market a New Drug: Patent Submission and Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not Be Infringed ......................................................................................................
Current Good Manufacturing Practice for Positron Emission .................................................................................
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E:\FR\FM\31DEN1.SGM
31DEN1
Date
approval
expires
0910–0309
0910–0393
10/31/2022
10/31/2022
0910–0513
0910–0667
10/31/2022
10/31/2022
]]>Agencies
[Federal Register Volume 84, Number 250 (Tuesday, December 31, 2019)]
[Notices]
[Pages 72366-72367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-28270]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-P-3877]
Determination That GLUCOPHAGE (Metformin Hydrochloride) Oral
Tablets, 500 Milligrams, 850 Milligrams, and 1 Gram, and GLUCOPHAGE XR
(Metformin Hydrochloride) Oral Extended-Release Tablets, 500 Milligrams
and 750 Milligrams, 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, Agency, or we) has
determined that, GLUCOPHAGE (metformin hydrochloride) oral tablets, 500
milligrams (mg), 850 mg, and 1 gram (g), and GLUCOPHAGE XR (metformin
hydrochloride) oral extended-release tablets, 500 mg and 750 mg, were
not withdrawn from sale for reasons of safety or effectiveness. This
determination means that FDA will not begin procedures to withdraw
approval of abbreviated new drug applications (ANDAs) that refer to
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to these products as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Carlarease Hunter, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-
796-3702, [email protected].
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
[[Page 72367]]
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.
GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 mg, 850 mg,
and 1 g, are the subject of NDA 020357, held by EMD Serono Inc. and
initially approved on March 3, 1995. GLUCOPHAGE is indicated as an
adjunct to diet and exercise to improve glycemic control in adults and
pediatric patients 10 years of age and older with type 2 diabetes
mellitus. GLUCOPHAGE (metformin hydrochloride) oral tablets, 500 mg,
850 mg, and 1 g, are currently listed in the ``Discontinued Drug
Product List'' section of the Orange Book.
GLUCOPHAGE XR (metformin hydrochloride) oral extended-release
tablets, 500 mg and 750 mg, are the subject of NDA 021202, held by EMD
Serono Inc. and initially approved on October 13, 2000. GLUCOPHAGE XR
is indicated as an adjunct to diet and exercise to improve glycemic
control in adults with type 2 diabetes mellitus. GLUCOPHAGE XR
(metformin hydrochloride) oral extended-release tablets, 500 mg and 750
mg, are currently listed in the ``Discontinued Drug Product List''
section of the Orange Book.
Harman Finochem Ltd. submitted a citizen petition dated August 17,
2019 (Docket No. FDA-2019-P-3877), under 21 CFR 10.30, requesting that
FDA confirm that GLUCOPHAGE (metformin hydrochloride) oral tablets were
not withdrawn from sale for reasons of safety or effectiveness.
Although the citizen petition did not address the GLUCOPHAGE XR
(metformin hydrochloride) oral extended-release tablets, 500 mg and 750
mg, those products have also been discontinued. On our own initiative,
we have also determined whether those products were withdrawn for
safety or effectiveness reasons.
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 GLUCOPHAGE (metformin hydrochloride) oral
tablets, 500 mg, 850 mg, and 1 g, and GLUCOPHAGE XR (metformin
hydrochloride) oral extended-release tablets, 500 mg and 750 mg, were
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that GLUCOPHAGE
(metformin hydrochloride) oral tablets were withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of GLUCOPHAGE (metformin
hydrochloride) oral tablets, 500 mg, 850 mg, and 1 g, and GLUCOPHAGE XR
(metformin hydrochloride) oral extended-release tablets, 500 mg and 750
mg, 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 these drug products were not
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list GLUCOPHAGE (metformin
hydrochloride) oral tablets, 500 mg, 850 mg, and 1 g, and GLUCOPHAGE XR
(metformin hydrochloride) oral extended-release tablets, 500 mg and 750
mg, 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. FDA will not begin
procedures to withdraw approval of approved ANDAs that refer to these
drug products. Additional ANDAs for these drug products may also 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: December 26, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-28270 Filed 12-30-19; 8:45 am]
BILLING CODE 4164-01-P
