Notice2022-09944
Determination That GLUCOTROL (Glipizide) Tablets, 2.5 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
May 10, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) has determined that GLUCOTROL (glipizide) tablets, 2.5 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for glipizide tablets, 2.5 mg, if all other legal and regulatory requirements are met.
Full Text
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<title>Federal Register, Volume 87 Issue 90 (Tuesday, May 10, 2022)</title>
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[Federal Register Volume 87, Number 90 (Tuesday, May 10, 2022)]
[Notices]
[Pages 28015-28016]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-09944]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0939]
Determination That GLUCOTROL (Glipizide) Tablets, 2.5 Milligrams,
Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) has
determined that GLUCOTROL (glipizide) tablets, 2.5 milligrams (mg),
were not withdrawn from sale for reasons of safety or effectiveness.
This determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for glipizide tablets, 2.5 mg, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Dan Ritterbeck, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 301-
796-4673, <a href="/cdn-cgi/l/email-protection#b7f3d6d9ded2db99e5dec3c3d2c5d5d2d4dcf7d1d3d699dfdfc499d0d8c1"><span class="__cf_email__" data-cfemail="d793b6b9beb2bbf985bea3a3b2a5b5b2b4bc97b1b3b6f9bfbfa4f9b0b8a1">[email protected]</span></a>.
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, 2.5 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.
[[Page 28016]]
GLUCOTROL (glipizide) tablets, 2.5 mg, are currently listed in the
``Discontinued Drug Product List'' section of the Orange Book.
Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated
August 24, 2021 (Docket No. FDA-2021-P-0939), under 21 CFR 10.30,
requesting that the Agency determine whether GLUCOTROL (glipizide)
tablets, 2.5 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, 2.5 mg, were
not withdrawn for reasons of safety or effectiveness. The petitioner
has identified no data or other information suggesting that GLUCOTROL
(glipizide) tablets, 2.5 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of GLUCOTROL (glipizide) tablets, 2.5 mg,
from sale. We have also independently evaluated relevant literature and
data for possible postmarketing adverse events. We have found no
information that would indicate that this drug product was withdrawn
from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list GLUCOTROL (glipizide)
tablets, 2.5 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. ANDAs that
refer to GLUCOTROL (glipizide) tablets, 2.5 mg, 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 this
drug product should be revised to meet current standards, the Agency
will advise ANDA applicants to submit such labeling.
Dated: May 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-09944 Filed 5-9-22; 8:45 am]
BILLING CODE 4164-01-P
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