Determination That FORTAMET (Metformin Hydrochloride) Extended-Release Tablets, 500 Milligrams and 1 Gram, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 36611 [2019-16008]
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36611
Federal Register / Vol. 84, No. 145 / Monday, July 29, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Surveys, focus groups, and interviews ................................
300
2
600
1
600
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
We base our estimate of the average
burden per response on review activities
familiar to the Agency.
Dated: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16027 Filed 7–26–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–P–2559]
Determination That FORTAMET
(Metformin Hydrochloride) ExtendedRelease Tablets, 500 Milligrams and 1
Gram, Were Not Withdrawn From Sale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 or Agency) has
determined that FORTAMET
(metformin hydrochloride) extendedrelease tablets, 500 milligrams (mg) and
1 gram (g), were not withdrawn from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.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
khammond on DSKBBV9HB2PROD with NOTICES
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.
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
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:54 Jul 26, 2019
Jkt 247001
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.
FORTAMET (metformin
hydrochloride) extended-release tablets,
500 mg and 1 g, are the subject of NDA
021574, held by Andrx Labs, LLC, and
initially approved on April 27, 2004.
FORTAMET is indicated as an adjunct
to diet and exercise to improve glycemic
control in adults with type 2 diabetes
mellitus.
FORTAMET (metformin
hydrochloride) extended-release tablets,
500 mg and 1 g, are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book. Ajanta
Pharma Limited submitted a citizen
petition dated May 27, 2019 (Docket No.
FDA–2019–P–2559), under 21 CFR
10.30, requesting that the Agency
determine whether FORTAMET
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
(metformin hydrochloride) extendedrelease tablets, 500 mg and 1 g, 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 FORTAMET (metformin
hydrochloride) extended-release tablets,
500 mg and 1 g, were not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that FORTAMET
(metformin hydrochloride) extendedrelease tablets, 500 mg and 1 g, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
FORTAMET (metformin hydrochloride)
extended-release tablets, 500 mg and 1
g, from sale. We have also
independently evaluated relevant
literature and data for possible post
marketing 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 FORTAMET (metformin
hydrochloride) extended-release tablets,
500 mg and 1 g, 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 this drug product. Additional ANDAs
for this drug product 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: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–16008 Filed 7–26–19; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\29JYN1.SGM
29JYN1
]]>Agencies
[Federal Register Volume 84, Number 145 (Monday, July 29, 2019)]
[Notices]
[Page 36611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16008]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-P-2559]
Determination That FORTAMET (Metformin Hydrochloride) Extended-
Release Tablets, 500 Milligrams and 1 Gram, 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 or Agency) has
determined that FORTAMET (metformin hydrochloride) extended-release
tablets, 500 milligrams (mg) and 1 gram (g), 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 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.
FORTAMET (metformin hydrochloride) extended-release tablets, 500 mg
and 1 g, are the subject of NDA 021574, held by Andrx Labs, LLC, and
initially approved on April 27, 2004. FORTAMET is indicated as an
adjunct to diet and exercise to improve glycemic control in adults with
type 2 diabetes mellitus.
FORTAMET (metformin hydrochloride) extended-release tablets, 500 mg
and 1 g, are currently listed in the ``Discontinued Drug Product List''
section of the Orange Book. Ajanta Pharma Limited submitted a citizen
petition dated May 27, 2019 (Docket No. FDA-2019-P-2559), under 21 CFR
10.30, requesting that the Agency determine whether FORTAMET (metformin
hydrochloride) extended-release tablets, 500 mg and 1 g, 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 FORTAMET (metformin hydrochloride) extended-
release tablets, 500 mg and 1 g, were not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that FORTAMET (metformin hydrochloride)
extended-release tablets, 500 mg and 1 g, were withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of FORTAMET (metformin hydrochloride)
extended-release tablets, 500 mg and 1 g, from sale. We have also
independently evaluated relevant literature and data for possible post
marketing 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 FORTAMET (metformin
hydrochloride) extended-release tablets, 500 mg and 1 g, 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 this drug product. Additional
ANDAs for this drug product 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: July 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-16008 Filed 7-26-19; 8:45 am]
BILLING CODE 4164-01-P
