Determination That ANTIZOL (Fomepizole) Injection, 1.5 Grams/1.5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 72608 [2021-27699]
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72608
Federal Register / Vol. 86, No. 243 / Wednesday, December 22, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–P–0923]
Determination That ANTIZOL
(Fomepizole) Injection, 1.5 Grams/1.5
Milliliters, Was Not Withdrawn From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 or Agency) has
determined that ANTIZOL (fomepizole)
Injection, 1.5 grams (g)/1.5 milliliters
(mL), was not withdrawn from sale for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 this drug product,
and it will allow FDA to continue to
approve ANDAs that refer to the
product as long as the ANDAs meet
relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6272,
Silver Spring, MD 20993–0002, 240–
825–9944, Kaetochi.Okemgbo@
fda.hhs.gov.
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
khammond on DSKJM1Z7X2PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:55 Dec 21, 2021
Jkt 256001
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.
ANTIZOL (fomepizole) Injection, 1.5
g/1.5 mL, is the subject of NDA 020696,
held by Par Pharmaceuticals Inc., and
initially approved on December 4, 1997.
ANTIZOL is indicated as an antidote for
ethylene glycol (such as antifreeze) or
methanol poisoning, or for use in
suspected ethylene glycol or methanol
ingestion, either alone or in
combination with hemodialysis.
ANTIZOL (fomepizole) Injection, 1.5 g/
1.5 mL is currently listed in the
‘‘Discontinued Drug Product List’’
section of the Orange Book.
Gland Pharma Ltd. submitted a
citizen petition dated August 19, 2021
(Docket No. FDA–2021–P–0923), under
21 CFR 10.30, requesting that the
Agency determine whether ANTIZOL
(fomepizole) Injection, 1.5 g/1.5 mL,
was 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 ANTIZOL (fomepizole)
Injection, 1.5 g/1.5 mL, was not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that ANTIZOL (fomepizole)
Injection, 1.5 g/1.5 mL, was withdrawn
for reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
ANTIZOL (fomepizole) Injection, 1.5 g/
1.5 mL, 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 this drug product was
not withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ANTIZOL (fomepizole)
Injection, 1.5 g/1.5 mL, in the
‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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 this drug
product should be revised to meet
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: December 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–27699 Filed 12–21–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Center for Advancing
Translational Sciences; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the
cooperative agreement applications, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
Name of Committee: National Center for
Advancing Translational Sciences Special
Emphasis Panel; CTSA.
Date: January 26–27, 2022.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard, Room
1037, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Victor Henriquez, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Center for Advancing
Translational Sciences, National Institutes of
Health, 6701 Democracy Boulevard, Room
1037, Bethesda, MD 20892, (301) 435–0813,
henriquv@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.859, Pharmacology,
E:\FR\FM\22DEN1.SGM
22DEN1
Agencies
[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Notices]
[Page 72608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27699]
[[Page 72608]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0923]
Determination That ANTIZOL (Fomepizole) Injection, 1.5 Grams/1.5
Milliliters, 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 or Agency) has
determined that ANTIZOL (fomepizole) Injection, 1.5 grams (g)/1.5
milliliters (mL), was 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 this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as the
ANDAs meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6272, Silver Spring, MD 20993-0002, 240-
825-9944, [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.
ANTIZOL (fomepizole) Injection, 1.5 g/1.5 mL, is the subject of NDA
020696, held by Par Pharmaceuticals Inc., and initially approved on
December 4, 1997. ANTIZOL is indicated as an antidote for ethylene
glycol (such as antifreeze) or methanol poisoning, or for use in
suspected ethylene glycol or methanol ingestion, either alone or in
combination with hemodialysis. ANTIZOL (fomepizole) Injection, 1.5 g/
1.5 mL is currently listed in the ``Discontinued Drug Product List''
section of the Orange Book.
Gland Pharma Ltd. submitted a citizen petition dated August 19,
2021 (Docket No. FDA-2021-P-0923), under 21 CFR 10.30, requesting that
the Agency determine whether ANTIZOL (fomepizole) Injection, 1.5 g/1.5
mL, was 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 ANTIZOL (fomepizole) Injection, 1.5 g/1.5 mL,
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
ANTIZOL (fomepizole) Injection, 1.5 g/1.5 mL, was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of ANTIZOL (fomepizole) Injection,
1.5 g/1.5 mL, 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 this drug product
was not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list ANTIZOL (fomepizole)
Injection, 1.5 g/1.5 mL, 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 this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.
Dated: December 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27699 Filed 12-21-21; 8:45 am]
BILLING CODE 4164-01-P