Determination That GLUCOTROL (Glipizide) Tablets, 5 Milligrams and 10 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 24011 [2024-07268]
Download as PDF
<![CDATA[
24011
Federal Register / Vol. 89, No. 67 / Friday, April 5, 2024 / Notices
Instrument
Total
number of
respondents
Annual
number of
responses per
respondent
Average
burden hours
per response
Annual
burden hours
Tribal Early Childhood Facilities Application Guide .........................................
10
1
100
1,000
Authority: 42 U.S.C. 9858(c)(6); 45
CFR part 1303 Subpart E.
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–07292 Filed 4–4–24; 8:45 am]
BILLING CODE 4184–40–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–P–0105]
Determination That GLUCOTROL
(Glipizide) Tablets, 5 Milligrams and 10
Milligrams, Were Not Withdrawn From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 or Agency) has
determined that GLUCOTROL
(glipizide) tablets, 5 milligrams (mg) and
10 mg, were not withdrawn from sale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.
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Swati Rawani, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6221,
Silver Spring, MD 20993–0002, 240–
402–9917, Swati.Rawani@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
VerDate Sep<11>2014
16:44 Apr 04, 2024
Jkt 262001
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
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.
GLUCOTROL (glipizide) tablets, 5 mg
and 10 mg, are the subject of NDA
017783, held by Pfizer Inc., and initially
approved on May 8, 1984. GLUCOTROL
is indicated as an adjunct to diet and
exercise to improve glycemic control in
adults with type 2 diabetes mellitus.
In a letter dated June 30, 2022, Pfizer
Inc., notified FDA that GLUCOTROL
(glipizide) tablets, 5 mg and 10 mg, were
being discontinued, and FDA moved
these drug products to the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Graviti Pharmaceuticals Private
Limited submitted a citizen petition
dated January 3, 2024, Docket No. FDA–
2024–P–0105, under 21 CFR 10.30,
requesting that the Agency determine
whether GLUCOTROL (glipizide)
tablets, 5 mg and 10 mg, 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 GLUCOTROL (glipizide)
PO 00000
Frm 00051
Fmt 4703
Sfmt 9990
tablets, 5 mg and 10 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that GLUCOTROL (glipizide)
tablets, 5 mg and 10 mg, were
withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
GLUCOTROL (glipizide) tablets, 5 mg
and 10 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.1
Accordingly, the Agency will
continue to list GLUCOTROL (glipizide)
tablets, 5 mg and 10 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: April 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–07268 Filed 4–4–24; 8:45 am]
BILLING CODE 4164–01–P
1 FDA previously determined that GLUCOTROL
(glipizide) tablets, 2.5 mg, were not withdrawn from
sale for reasons of safety or effectiveness (87 FR
28015, May 10, 2022).
E:\FR\FM\05APN1.SGM
05APN1
]]>Agencies
[Federal Register Volume 89, Number 67 (Friday, April 5, 2024)]
[Notices]
[Page 24011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-07268]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-0105]
Determination That GLUCOTROL (Glipizide) Tablets, 5 Milligrams
and 10 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 or Agency) has
determined that GLUCOTROL (glipizide) tablets, 5 milligrams (mg) and 10
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: Swati Rawani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6221, Silver Spring, MD 20993-0002, 240-
402-9917, [email protected].
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act 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.
GLUCOTROL (glipizide) tablets, 5 mg and 10 mg, are the subject of
NDA 017783, held by Pfizer Inc., and initially approved on May 8, 1984.
GLUCOTROL is indicated as an adjunct to diet and exercise to improve
glycemic control in adults with type 2 diabetes mellitus.
In a letter dated June 30, 2022, Pfizer Inc., notified FDA that
GLUCOTROL (glipizide) tablets, 5 mg and 10 mg, were being discontinued,
and FDA moved these drug products to the ``Discontinued Drug Product
List'' section of the Orange Book.
Graviti Pharmaceuticals Private Limited submitted a citizen
petition dated January 3, 2024, Docket No. FDA-2024-P-0105, under 21
CFR 10.30, requesting that the Agency determine whether GLUCOTROL
(glipizide) tablets, 5 mg and 10 mg, 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 GLUCOTROL (glipizide) tablets, 5 mg and 10 mg,
were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
GLUCOTROL (glipizide) tablets, 5 mg and 10 mg, were withdrawn for
reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of GLUCOTROL (glipizide)
tablets, 5 mg and 10 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.\1\
---------------------------------------------------------------------------
\1\ FDA previously determined that GLUCOTROL (glipizide)
tablets, 2.5 mg, were not withdrawn from sale for reasons of safety
or effectiveness (87 FR 28015, May 10, 2022).
---------------------------------------------------------------------------
Accordingly, the Agency will continue to list GLUCOTROL (glipizide)
tablets, 5 mg and 10 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: April 2, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-07268 Filed 4-4-24; 8:45 am]
BILLING CODE 4164-01-P
